Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This randomized phase III trial is studying giving carboplatin, paclitaxel and gemcitabine together with or without bevacizumab after surgery to see how well it works in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases the duration of overall survival in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.

II. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases the duration of overall survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.

SECOND OBJECTIVES:

I. To determine if the addition of bevacizumab to the second-line and maintenance phase of treatment increases the duration of progression-free survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or Fallopian tube cancer.

II. To prospectively determine the incidence of carboplatin and paclitaxel hypersensitivity in these patients undergoing retreatment with both agents as first recurrence therapy.

III. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases quality of life (QOL) of patients with recurrent platinum-sensitive ovarian epithelial cancer or primary peritoneal cavity cancer, as measured by the FACT-O trial outcome index and Rand SF-36 physical functioning scale.

IV. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases QOL relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum-sensitive ovarian epithelial cancer or primary peritoneal cavity cancer.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 4 treatment groups. Patients who are not candidates for surgical cytoreduction (i.e., those for whom complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking) are eligible to receive chemotherapy after randomization.

Patients who are eligible for surgery undergo abdominal exploration with cytoreduction and undergo tumor tissue collection and complete a quality of life questionnaire before and after surgery. All patients are then randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or docetaxel IV over 1 hour and carboplatin IV over 60 minutes on day 1.

ARM II: Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1.

ARM III: Patients receive gemcitabine IV over 60 minutes on days 1and 8 and carboplatin as in arm I.

ARM IV: Patients receive gemcitabine IV as in arm III, bevacizumab IV and carboplatin IV as in arm II.

In all arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of therapy. Patients with stable disease or partial regression receive a maximum of 6 courses.

Patients without measurable lesions as determined by a computed tomography (CT) scan prior to initiating study treatment continue therapy for 6 courses or, if CA-125 normalizes, for 2 cycles beyond CA-125 normalization, whichever is greater. Patients in arm II then receive a maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment with bevacizumab alone repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 10 years.

Eligibility Criteria

Inclusion Criteria:

• Patients must have histologic diagnosis of ovarian epithelial carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent

• The following histologic epithelial cell types are eligible:

• Serous adenocarcinoma

• Endometrioid adenocarcinoma

• Mucinous adenocarcinoma

• Undifferentiated carcinoma

• Clear cell adenocarcinoma

• Mixed epithelial carcinoma

• Transitional cell carcinoma

• Malignant Brenner Tumor

• Adenocarcinoma not otherwise specified

• Patients must have had a complete response to front-line platinum-taxane therapy (at least 3 cycles) and a treatment-free interval without clinical evidence of progressive disease lasting at least 6 months

• A complete response to front-line chemotherapy must include the following:

• Negative physical exam

• Negative pelvic exam

• Normalization of CA125, if elevated at baseline

• Negative radiographic assessment of disease

• All patients must have also had a treatment-free interval without clinical evidence of progressive disease of at least 6 months from completion of front-line chemotherapy (both platinum and taxane); front-line therapy may have included a biologic agent

• Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy

• Patients must have clinically evident recurrent disease for the purpose of this study,

• Measurable disease (RECIST) is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be more than or equal to 20 mm when measured by conventional techniques, MRI or CT, or more than or equal to 10 mm when measured by spiral CT

• Absolute neutrophil count (ANC) >= 1,500/mm^3 equivalent to Common Toxicity Criteria for Adverse Events v3.0 (CTCAE) Grade1

• Platelet count >= 100,000/mm^3 (CTCAE Grade 0-1)

• Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 times upper limit of normal (ULN)

• Total bilirubin =< 1.5 times ULN

• Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =< 2.5 times ULN (< 5.0 times ULN in the presence of liver metastasis)

• Alkaline phosphatase =< 2.5 times ULN (< 5.0 times ULN in the presence of liver metastasis)

• Patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL

• Patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization; patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking

• Patients must have signed an approved informed consent and authorization permitting release of personal health information

• Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Exclusion Criteria:

• Patients who have more than one previous regimen of chemotherapy (maintenance therapy is not considered a second regimen)

• Patients receiving concurrent immunotherapy, or radiotherapy

• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded

• Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded

• Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided they meet the inclusion criteria above

• Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation

• Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer are excluded, unless all of the following conditions are met:

• Stage not greater than I-B;

• No more than superficial myometrial invasion, without vascular or lymphatic invasion;

• No poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions

• Patients with uncontrolled infection

• Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy

• Patients with peripheral neuropathy >= grade 2

• Patients with a history of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds; patients with allergic (hypersensitivity) reactions to these chemotherapeutic agents are NOT excluded IF they were successfully retreated following a desensitization program or protocol

• Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies

• Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant or patients who are nursing are not eligible for this trial; to date, no fetal studies in animal or humans have been performed; the possibility of harm to a fetus is likely; bevacizumab specifically inhibits VEGF, which is responsible for the formation of new blood vessels during development, and antibodies can cross the placenta; therefore, bevacizumab should not be administered to pregnant women; in addition, there are unknown immediate and long-term consequences of chemotherapy administration to these women; in addition, surgical exploration as mandated by randomization during pregnancy may cause imminent mortal consequences; further, it is not known whether bevacizumab is excreted in human milk; because many drugs are excreted in human milk, bevacizumab should not be administered to nursing women; subjects will be apprised of the large potential risk to a developing fetus

• Patients with other invasive malignancies, with the exception of nonmelanoma skin cancer, or patients who had (or have) any evidence of the other cancer present within the past 5 years or whose previous cancer treatment contraindicates this protocol therapy

• Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels

• Patients with a history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or a history of stroke within the past 5 years of the first date of treatment on this study

• Patients with clinically significant cardiovascular disease including any of the following:

• Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or 2nd or 3rd degree atrioventricular [AV] block )

• Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg

• Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months

• New York Heart Association (NYHA) grade II or greater congestive heart failure

• Serious cardiac arrhythmia requiring medication

• Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hrs in duration that are managed non-surgically and without permanent deficit

• History of cerebrovascular accident (CVA) within the past 6 months

• Patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study:

• Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with bevacizumab on cycle 2

• Patients undergoing pre-treatment surgery for purposes other than cytoreduction may also participate provided they meet eligibility; patients randomized to arms containing bevacizumab must wait a minimum of 28 days since that procedure to begin protocol treatment; patients who undergo an uncomplicated port placement must wait a minimum of 7 days to begin protocol treatment

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Robert L. Coleman

Principal Investigator

U.S.A.
Alaska
	Anchorage
	Providence Cancer Center
		Dennis Beckworth	Ph: 907-261-3109
Arizona
	Phoenix
	GOG of Arizona, PC
		Robert L. Coleman	Ph: 713-792-3245
			Email: rcoleman@mdanderson.org
California
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Babak Edraki	Ph: 925-674-2580
	Long Beach
	Todd Cancer Institute at Long Beach Memorial Medical Center
		Robert E Bristow	Ph: 877-827-8839
			Email: ucstudy@uci.edu
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Robin Farias-Eisner	Ph: 888-798-0719
	Kaiser Permanente Medical Center - Los Angeles
		Scott E. Lentz	Ph: 626-564-3455
		Scott E. Lentz	Ph: 626-564-3455
	Mountain View
	Palo Alto Medical Foundation
		Albert L Pisani	Ph: 650-934-7000
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Krishnansu S Tewari	Ph: 714-456-6191
			Email: awallick@uci.edu
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		John K Chan	Ph: 877-827-3222
Colorado
	Aurora
	Medical Center of Aurora - South Campus
		Eduardo R. Pajon	Ph: 888-785-6789
	University of Colorado Cancer Center at UC Health Sciences Center
		Susan Davidson	Ph: 720-848-0650
	Boulder
	Boulder Community Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo R. Pajon	Ph: 888-785-6789
	Porter Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Presbyterian - St. Luke's Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Rose Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Anthony Central Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Joseph Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Englewood
	Rocky Mountain Gynecologic Oncology
		Kevin P. Davis	Ph: 303-781-9090
	Swedish Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Littleton
	Littleton Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Lone Tree
	Sky Ridge Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Loveland
	McKee Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Parker
	Parker Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Thornton
	North Suburban Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Wheat Ridge
	Exempla Lutheran Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		James S. Hoffman	Ph: 860-224-5660
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		James S. Hoffman	Ph: 860-224-5660
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Mark E Borowsky	Ph: 302-733-6227
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Mark E Borowsky	Ph: 302-733-6227
Florida
	Fort Myers
	Florida Gynecologic Oncology - Fort Myers
		Edward C. Grendys	Ph: 800-874-7502
	Saint Petersburg
	Women's Cancer Associates
		James P. LaPolla	Ph: 800-230-6203
Georgia
	Augusta
	Medical College of Georgia Cancer Center
		Sharad Anant Ghamande	Ph: 706-721-1663
			Email: cancer@georgiahealth.edu
	Columbus
	John B. Amos Cancer Center
		John L Currie	Ph: 860-545-5363
	Gainesville
	Northeast Georgia Medical Center
		Andrew E Green	Ph: 770-219-8800
			Email: cancerpatient.navigator@nghs.com
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		James J Burke	Ph: 912-350-8568
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Philip J. Stella	Ph: 734-712-3456
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Julian C. Schink	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Rush Cancer Institute at Rush University Medical Center
		Jacob Rotmensch	Ph: 312-942-5498
			Email: clinical_trials@rush.edu
	University of Chicago Cancer Research Center
		Seiko Diane Yamada	Ph: 773-834-7424
	Hinsdale
	Gynecologic Oncology
		Sudarshan K. Sharma	Ph: 630-856-6757
	Springfield
	Regional Cancer Center at Memorial Medical Center
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		David L Graham	Ph: 800-446-5532
Indiana
	Elkhart
	Elkhart Clinic, LLC
		Michael Rodriguez	Ph: 574-237-1328
	Elkhart General Hospital
		Michael Rodriguez	Ph: 574-237-1328
	Michiana Hematology-Oncology, PC - Elkhart
		Michael Rodriguez	Ph: 574-237-1328
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Jeanne M Schilder	Ph: 317-274-2552
	St. Vincent Oncology Center
		Gregory P. Sutton	Ph: 317-338-2194
	Kokomo
	Community Cancer Care at Howard Regional Health System
		Michael Rodriguez	Ph: 574-237-1328
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Michael Rodriguez	Ph: 574-237-1328
	Mishawaka
	Michiana Hematology-Oncology, PC - Mishawaka
		Michael Rodriguez	Ph: 574-237-1328
	Saint Joseph's Medical Center
		Michael Rodriguez	Ph: 574-237-1328
	Munster
	Community Hospital
		Mohamad Kassar	Ph: 219-836-3349
	Plymouth
	Michiana Hematology Oncology PC - Plymouth
		Michael Rodriguez	Ph: 574-237-1328
	South Bend
	CCOP - Northern Indiana CR Consortium
		Michael Rodriguez	Ph: 574-237-1328
	Memorial Hospital of South Bend
		Michael Rodriguez	Ph: 574-237-1328
	Michiana Hematology-Oncology, PC - South Bend
		Michael Rodriguez	Ph: 574-237-1328
	Westville
	Michiana Hematology Oncology-PC Westville
		Michael Rodriguez	Ph: 574-237-1328
Iowa
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Koen De Geest	Ph: 800-237-1225
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker R. Dakhil	Ph: 316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker R. Dakhil	Ph: 316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker R. Dakhil	Ph: 316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker R. Dakhil	Ph: 316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker R. Dakhil	Ph: 316-262-4467
	Kansas City
	Providence Medical Center
		Rakesh Gaur	Ph: 913-948-5588
			Email: amy.krushelniski@hcahealthcare.com
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker R. Dakhil	Ph: 316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker R. Dakhil	Ph: 316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker R. Dakhil	Ph: 316-262-4467
	Overland Park
	Saint Luke's Hospital - South
		Rakesh Gaur	Ph: 913-948-5588
			Email: amy.krushelniski@hcahealthcare.com
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker R. Dakhil	Ph: 316-262-4467
	Prairie Village
	CCOP - Kansas City
		Rakesh Gaur	Ph: 913-948-5588
			Email: amy.krushelniski@hcahealthcare.com
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker R. Dakhil	Ph: 316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker R. Dakhil	Ph: 316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker R. Dakhil	Ph: 316-262-4467
	Wichita
	Associates in Women's Health, PA - North Hillside
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	CCOP - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker R. Dakhil	Ph: 316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker R. Dakhil	Ph: 316-262-4467
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Amanda N Fader	Ph: 443-849-3706
	Elkton MD
	Union Hospital of Cecil County
		Mark E Borowsky	Ph: 302-733-6227
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip J. Stella	Ph: 734-712-3456
	Saint Joseph Mercy Cancer Center
		Philip J. Stella	Ph: 734-712-3456
	University of Michigan Comprehensive Cancer Center
		Carolyn M. Johnston	Ph: 734-712-3456
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Gilbert D Padula	Ph: 616-685-5225
	Big Rapids
	Mecosta County Medical Center
		Gilbert D Padula	Ph: 616-685-5225
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Thomas E Buekers	Ph: 313-916-1784
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Wayne State University
		Robert T. Morris	Ph: 313-576-9363
	Flint
	Hurley Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Grand Blanc
	Genesys Regional Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Gilbert D Padula	Ph: 616-685-5225
	CCOP - Grand Rapids
		Gilbert D Padula	Ph: 616-685-5225
	Gynecologic Oncology of West Michigan
		Gordon O. Downey	Ph: 616-957-3398
	Lacks Cancer Center at Saint Mary's Health Care
		Gilbert D Padula	Ph: 616-685-5225
	Jackson
	Gayle M. Jacob Cancer Center at Allegiance Health
		Philip J. Stella	Ph: 734-712-3456
	Kalamazoo
	Borgess Medical Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Bronson Methodist Hospital
		Raymond Sterling Lord	Ph: 269-373-7458
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Philip J. Stella	Ph: 734-712-3456
	Livonia
	St. Mary Mercy Hospital
		Philip J. Stella	Ph: 734-712-3456
	Muskegon
	Mercy General Health Partners
		Gilbert D Padula	Ph: 616-685-5225
	Pontiac
	St. Joseph Mercy Oakland
		Philip J. Stella	Ph: 734-712-3456
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip J. Stella	Ph: 734-712-3456
	Reed City
	Spectrum Health Reed City Hospital
		Gilbert D Padula	Ph: 616-685-5225
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Philip J. Stella	Ph: 734-712-3456
	Saint Joseph
	Lakeside Cancer Specialists, PLLC
		Michael Rodriguez	Ph: 574-237-1328
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Michael Rodriguez	Ph: 574-237-1328
	Traverse City
	Munson Medical Center
		Gilbert D Padula	Ph: 616-685-5225
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Duluth
	St. Luke's Hospital Cancer Care Center
		Tanya L. Repka
			Email: sgriffin@gog.org
	Edina
	Fairview Southdale Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Hutchinson
	Hutchinson Area Health Care
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minnesota Oncology - Maplewood
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	New Ulm
	New Ulm Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Louis Park
	CCOP - Metro-Minnesota
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Park Nicollet Cancer Center
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Paul
	Regions Hospital Cancer Care Center
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	United Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Stillwater
	Lakeview Hospital
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Waconia
	Ridgeview Medical Center
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Woodbury
	Minnesota Oncology - Woodbury
		Matthew P Boente	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Mississippi
	Jackson
	St. Dominic Cancer Center
		Donald P Seago	Ph: 601-200-3300
	University of Mississippi Cancer Clinic
		James Tate Thigpen	Ph: 601-815-6700
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James E. Clarkson	Ph: 228-809-5292
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Mark I Hunter	Ph: 573-882-7440
	Kansas City
	Saint Luke's Hospital
		Rakesh Gaur	Ph: 913-948-5588
			Email: amy.krushelniski@hcahealthcare.com
	Lee's Summit
	Saint Luke's East - Lee's Summit
		Rakesh Gaur	Ph: 913-948-5588
			Email: amy.krushelniski@hcahealthcare.com
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David Gardner Mutch	Ph: 800-600-3606
			Email: info@ccadmin.wustl.edu
	Springfield
	Cancer Research for the Ozarks
		Robert L Carolla	Ph: 417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert L Carolla	Ph: 417-269-4520
	St. John's Regional Health Center
		Robert L Carolla	Ph: 417-269-4520
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Peter C. Morris	Ph: 402-354-7939
			Email: kathryn.bartz@nmhs.org
Nevada
	Las Vegas
	Women's Cancer Center - La Canada
		Nick M. Spirtos	Ph: 702-851-4672
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Peter C Lim	Ph: 866-513-8227
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		David P. Warshal	Ph: 856-325-6757
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Daniel H Tobias	Ph: 973-971-5900
	Mount Holly
	Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
		Randolph B Deger	Ph: 888-847-8823
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Darlene G. Gibbon	Ph: 732-235-8675
	Phillipsburg
	Women’s Institute for Gynecologic Cancer and Special Pelvic Surgery
		David Foster Silver	Ph: 718-765-2500
New Mexico
	Albuquerque
	Southwest Gynecologic Oncology Associates, Incorporated
		Carolyn Y. Muller	Ph: 505-272-6972
	University of New Mexico Cancer Center
		Carolyn Y. Muller	Ph: 505-272-6972
	Las Cruces
	Memorial Medical Center
		Carolyn Y. Muller	Ph: 505-272-6972
New York
	Albany
	Women's Cancer Care Associates
		Thomas P Morrissey	Ph: 518-458-1390
	Brooklyn
	SUNY Downstate Medical Center
		Ovadia Abulafia	Ph: 718-270-8216
			Email: sima.terebelo@downstate.edu
	Lake Success
	Monter Cancer Center of the North Shore-LIJ Health System
		Veena S John	Ph: 516-562-3467
	Manhasset
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Veena S John	Ph: 516-562-3467
	New Hyde Park
	Long Island Jewish Medical Center
		Veena S John	Ph: 516-562-3467
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Thomas J. Herzog	Ph: 212-305-8615
	Memorial Sloan-Kettering Cancer Center
		Mario M Leitao	Ph: 212-639-7202
	New York University Medical Center
		Stephanie V. Blank	Ph: 212-263-4434
			Email: prmc.coordinator@nyumc.org
	Stony Brook
	Stony Brook University Cancer Center
		Michael L. Pearl	Ph: 800-862-2215
	Syracuse
	SUNY Upstate Medical University Hospital
		Mary J Cunningham	Ph: 315-464-5476
North Carolina
	Burlington
	Alamance Cancer Center at Alamance Regional Medical Center
		Janak K. Choksi	Ph: 336-538-7725
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Linda Van Le	Ph: 877-668-0683
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Robert Victor Higgins	Ph: 704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		John M McDonald	Ph: 704-384-5369
	Durham
	Duke Cancer Institute
		Angeles Alvarez Secord	Ph: 888-275-3853
	Greensboro
	Moses Cone Regional Cancer Center at Wesley Long Community Hospital
		Peter Rubin	Ph: 336-832-0821
	Raleigh
	Duke Health Raleigh Hospital
		Angeles Alvarez Secord	Ph: 888-275-3853
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Samuel S. Lentz	Ph: 336-713-6771
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Esther H. Rehmus	Ph: 330-344-6348
	Summa Center for Cancer Care at Akron City Hospital
		Vivian von Gruenigen	Ph: 330-375-6101
	Canton
	Aultman Cancer Center at Aultman Hospital
		Michael P. Hopkins	Ph: 330-363-6891
	Cincinnati
	University of Cincinnati
		Thomas J. Reid	Ph: 937-298-3399
			Email: uchealthnews@uc.edu
	Cleveland
	Case Comprehensive Cancer Center
		Steven E. Waggoner	Ph: 800-641-2422
	Cleveland Clinic Cancer Center at Fairview Hospital
		Peter Graham Rose	Ph: 866-223-8100
	Cleveland Clinic Taussig Cancer Center
		Peter Graham Rose	Ph: 866-223-8100
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Peter Graham Rose	Ph: 866-223-8100
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		David Elliot Cohn	Ph: 866-627-7616
			Email: osu@emergingmed.com
	Riverside Methodist Hospital Cancer Care
		Jeffrey G. Bell	Ph: 614-566-4475
	Dayton
	David L. Rike Cancer Center at Miami Valley Hospital
		John W Moroney	Ph: 937-208-2079
	Kettering
	Charles F. Kettering Memorial Hospital
		Heather S Pulaski	Ph: 937-298-3399
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		Peter Graham Rose	Ph: 866-223-8100
	Mentor
	Lake/University Ireland Cancer Center
		Steven E. Waggoner	Ph: 800-641-2422
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert S. Mannel	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
	Tulsa
	Cancer Care Associates-Yale
		Robert S. Mannel	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Parviz Hanjani	Ph: 215-481-2402
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Richard M. Boulay	Ph: 610-402-2273
	Danville
	Geisinger Cancer Institute at Geisinger Health
		James R Bosscher	Ph: 570-271-5251
			Email: ehicks@sprg.mercy.net
	Hazleton
	Geisinger Hazleton Cancer Center
		James R Bosscher	Ph: 570-271-5251
			Email: ehicks@sprg.mercy.net
	Hershey
	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
		James Fanning	Ph: 717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Stephen C. Rubin	Ph: 215-746-7406
	Fox Chase Cancer Center - Philadelphia
		Mark A. Morgan	Ph: 215-728-4790
	Gynecologic Oncology Group
		Robert L. Coleman	Ph: 713-745-3357
			Email: rcoleman@mdanderson.org
	Joan Karnell Cancer Center at Pennsylvania Hospital
		Patricia A. Ford	Ph: 800-789-7366
	Temple Cancer Center at Temple University Hospital
		Enrique Hernandez	Ph: 215-728-2983
	State College
	Geisinger Medical Group - Scenery Park
		James R Bosscher	Ph: 570-271-5251
			Email: ehicks@sprg.mercy.net
	West Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Bernice L Robinson-Bennett	Ph: 610-988-9323
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		James R Bosscher	Ph: 570-271-5251
			Email: ehicks@sprg.mercy.net
Rhode Island
	Providence
	Women and Infants Hospital of Rhode Island
		Paul A. DiSilvestro	Ph: 401-274-1122
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Whitney S Graybill	Ph: 843-792-9321
South Dakota
	Rapid City
	Black Hills Obstetrics & Gynecology LLP
		Helen L. Frederickson	Ph: 605-343-9224
	Sioux Falls
	Avera Cancer Institute
		Luis A Rojas-Espaillat	Ph: 800-657-4377
			Email: Jan.Healy@avera.org
	Sanford Cancer Center at Sanford USD Medical Center
		Maria C. Bell	Ph: 218-333-5000
		Maria C. Bell	Ph: 218-333-5000
Texas
	Austin
	University Medical Center Brackenridge
		Mark A Crozier	Ph: 512-324-7991
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		David Scott Miller	Ph: 214-648-7097
	Galveston
	University of Texas Medical Branch
		Lyuba Levine	Ph: 409-772-1950
			Email: clinical.research@utmb.edu
	Houston
	Memorial Hermann - Texas Medical Center
		Larissa A Meyer
			Email: sgriffin@gog.org
	Methodist Hospital
		Aparna A Kamat	Ph: 281-277-5200
	Univeristy of Texas M.D. Anderson Cancer Center
		Robert L. Coleman	Ph: 713-792-3245
Utah
	Ogden
	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Provo
	Utah Valley Regional Medical Center - Provo
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Saint George
	Dixie Regional Medical Center - East Campus
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Theresa L Werner	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	LDS Hospital
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
Vermont
	Burlington
	Fletcher Allen Health Care - Medical Center Campus
		Cheung Wong	Ph: 802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Susan C Modesitt	Ph: 434-243-6143
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Weldon E Chafe	Ph: 804-628-1939
	Roanoke
	Carilion Clinic Gynecological Oncology
		Janet L. Osborne	Ph: 540-985-8510
Washington
	Bellingham
	PeaceHealth Medical Group, PC at St. Joseph Hospital
		Benjamin E. Greer	Ph: 206-616-8289
	Bremerton
	Harrison Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
	Olympic Hematology and Oncology
		Benjamin E. Greer	Ph: 206-616-8289
	Everett
	Providence Regional Cancer Partnership
		Benjamin E. Greer	Ph: 206-616-8289
	Mount Vernon
	Skagit Valley Hospital Cancer Care Center
		Benjamin E. Greer	Ph: 206-616-8289
	Poulsbo
	Harrison Poulsbo Hematology and Onocology
		Benjamin E. Greer	Ph: 206-616-8289
	Seattle
	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
		Benjamin E. Greer	Ph: 206-616-8289
	Group Health Central Hospital
		Benjamin E. Greer	Ph: 206-616-8289
	Pacific Gynecology Specialists
		Benjamin E. Greer	Ph: 206-616-8289
	Seattle Cancer Care Alliance
		Benjamin E. Greer	Ph: 206-616-8289
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Benjamin E. Greer	Ph: 206-616-8289
	Swedish Cancer Institute at Northwest Hospital & Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
	University Cancer Center at University of Washington Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
	Sequim
	Olympic Medical Cancer Center
		Benjamin E. Greer	Ph: 206-616-8289
	Spokane
	Cancer Care Northwest - Spokane South
		Benjamin E. Greer	Ph: 206-616-8289
	Rockwood Clinic Cancer Treatment Center
		Benjamin E. Greer	Ph: 206-616-8289
	Tacoma
	Franciscan Cancer Center at St. Joseph Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Benjamin E. Greer	Ph: 206-616-8289
	Walla Walla
	St. Mary Regional Cancer Center at St. Mary Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
	Wenatchee
	Wenatchee Valley Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Jonathan E Tammela	Ph: 920-433-8889
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Jonathan E Tammela	Ph: 920-433-8889
	St. Vincent Hospital Regional Cancer Center
		Jonathan E Tammela	Ph: 920-433-8889
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Sigurdur Bodvarsson	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		David M Kushner	Ph: 877-405-6866
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Jonathan E Tammela	Ph: 920-433-8889
	Milwaukee
	Aurora Sinai Medical Center
		Ali Mahdavi	Ph: 414-649-5717
			Email: ucstudy@uci.edu
	Froedtert Hospital and Medical College of Wisconsin
		William H Bradley	Ph: 414-805-4380
	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
		Scott A Kamelle	Ph: 414-649-7200
	New Richmond
	Cancer Center of Western Wisconsin
		Joseph W Leach	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Sheboygan
	Vince Lombardi Cancer Clinic - Sheboygan
		Santhosh Kumar	Ph: 414-649-7200
	Two Rivers
	Vince Lombardi Cancer Clinic - Two Rivers
		Andrew W Yetter	Ph: 800-252-2990
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Christopher G Peterson	Ph: 877-405-6866
	West Allis
	Aurora Women's Pavilion of West Allis Memorial Hospital
		Peter Johnson	Ph: 800-252-2990
Japan
	Hiroshima City
	Hiroshima University Hospital
		Eiji Hirata	Ph:  82-424-6042
	Kagoshima City, Kagoshima
	Kagoshima City Hospital
		Masayuki Hatae	Ph: 011 81 099 224 2101
	Saitama
	Saitama Medical University International Medical Center
		Keiichi Fujiwara	Ph:  81-49-276-2028
	Tokyo
	National Cancer Center Hospital
		Mayu Yunokawa	Ph:  81-3-3542-2511
			Email: www-admin@ncc.go.jp
	Tottori
	Tottori University Hospital
		Junzo Kigawa	Ph: 0857-31-5007
Aoba-ku
	Sendai
	Tohoku University Graduate School of Medicine
		Nobuo Yaegashi
			Email: med-som@bureau.tohoku.ac.jp
Hiroshima
	Kure
	National Hospital Organization - Medical Center of Kure
		Kazuhiro Takehara	Ph: 089-999-1172
Hokkaido
	Sapporo
	Hokkaido University Hospital
		Noriaki Sakuragi
			Email: hassi@med.hokudai.ac.jp
Iwate
	Morioka
	Iwate Medical University Hospital
		Toru Sugiyama	Ph: 019-651-5111
Niigata
	Niigata City
	Niigata University Medical and Dental Hospital
		Tetsuro Yahata	Ph: 81-025-223-6161
Suntou
	Shizuoka City
	Shizuoka Cancer Center
		Munetaka Takekuma
			Email: sgriffin@gog.org
Tokyo
	Shinjuku-ku
	Keio University Hospital
		Daisuke Aoki	Ph:  03 5363-3848
Republic of Korea
	Seoul
	Asan Medical Center - University of Ulsan College of Medicine
		Joo-Hyun Nam	Ph: irbksh@amc.seoul.kr
	Gangnam Severance Hospital
		Jae-Hoon Kim
			Email: clinical.trial@bms.com
	Korea Cancer Center Hospital
		Moon-Hong Kim	Ph: 011-82-02-9702-114
	Seoul National University Hospital
		Soon-Beom Kang	Ph: 011-82-760-2384
	Suwon
	Ajou University Hospital
		Hee-Sug Ryu	Ph:  031 219-4311~2
Daegu
	Jung-Ku
	Dongsan Medical Center of Keimyung University
		Chi-Heum Cho
			Email: ho@dsmc.or.kr
Gyeonggi-do
	Goyang-si
	National Cancer Center - Korea
		Sang Y Park	Ph: 011-82-760-2384
KOREA
	Seoul
	Samsung Medical Center
		Duk-Soo Bae	Ph: 011-82-1599-3114
Kyeonggi-do
	Seongnam City
	Seoul National University Bundang Hospital
		Yong Beom Kim	Ph: 011-82-760-2384

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00565851
Information obtained from ClinicalTrials.gov on April 04, 2013

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