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 carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II, stage III, stage IV, or recurrent stage I epithelial ovarian cancer or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, 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 which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.

II. To determine if bevacizumabreduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.

SECONDARY OBJECTIVES:

I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.

II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.

III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.

IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.

V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients.

VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients.

VII. To compare capecitabine and oxaliplatin versus carboplatin and paclitaxel with respect to changes in patient reported neurotoxicity.

VIII. To determine the impact on Quality of Life (QOL, as measured by the FACT-O TOI) following treatment with the above regimens.

TERTIARY OBJECTIVES:

I. To collect fixed and/or frozen tissue and whole blood for future research studies.

OUTLINE: This is a multicenter study. Patients are stratified according to disease status (no gross residual disease [i.e., 0] vs residual disease [> 0]), disease stage (recurrent stage I [chemonaive] vs stage II-IV), and country (U.S. vs non-U.S.). Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and oral capecitabine twice a day on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.

Patients complete quality-of-life questionnaires (FACT-O TOI, FACT/GOG-NTX Subscale, and EQ-5D) at baseline, during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3-5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Eligibility Criteria

Inclusion Criteria:

• Histologically confirmed mucinous carcinoma of the ovary or fallopian tube

• Cytological (e.g., fine-needle aspiration) examination is inadequate for diagnosis

• No epithelial non-mucinous cell types

• Meets 1 of the following staging criteria:

• FIGO stage II-IV disease

• Recurrent stage I disease (chemonaïve)

• Patients must have a negative colonoscopy within 1 year before study entry

• No primary peritoneal carcinoma

• No epithelial ovarian tumors of low malignant potential

• No known brain metastases

• ECOG performance status 0-2

• Life expectancy > 3 months

• WBC ≥ 3 x 10^9/L

• Absolute neutrophil count ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Hemoglobin ≥ 10 g/dL (may be post-transfusion)

• Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)

• Serum transaminases ≤ 2.5 x ULN

• Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 50 mL/min

• Urine dipstick for proteinuria < 2+ OR 24-hour urine protein ≤ 1 g

• INR ≤ 1.5 x ULN

• APTT ≤ 1.5 x ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Adequate neurological function (sensory and motor neuropathy ≤ grade 1)

• No prior or concurrent peripheral neuropathy

• No evidence of upper GI cancer (e.g., pancreatic cancer) on CT or MRI scan

• No history of another malignancy except carcinoma in situ of the cervix or basal cell carcinoma of the skin

• No medical or psychiatric conditions that compromise the patient's ability to give informed consent

• No clinically significant cardiac disease, symptomatic coronary artery disease, or congestive heart failure

• No peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision), cardiac arrhythmia, or myocardial infarction within the past 12 months

• No known hypersensitivity to bevacizumab and its excipients or to chemotherapy (including cremophor)

• No history of malabsorption or other conditions preventing oral treatment

• No nonhealing wound, ulcer, or bone fracture (patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible provided they undergo three weekly wound examinations)

• No history or evidence of thrombotic or hemorrhagic disorders

• No uncontrolled hypertension (sustained elevation of BP > 150/100 mmHg despite antihypertensive therapy)

• No significant traumatic injury within the past 4 weeks

• No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months

• No other concurrent uncontrolled medical conditions

• No prior chemotherapy

• No prior radiotherapy or investigational treatment for ovarian or rectal cancer

• No prior mouse CA125 antibody

• At least 10 days since prior and no concurrent chronic use of aspirin (> 325 mg/day)

• Prophylactic low-dose aspirin (≤ 325 mg/day) in patients who are at risk of an arterial thromboembolic event allowed

• At least 4 weeks since prior surgery or open biopsy and no planned surgery during the 58-week period from the start of study treatment

• No second-look surgery

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

David Gershenson

Principal Investigator

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Warner Huh	Ph: 205-934-0309
Arizona
	Phoenix
	St. Joseph's Hospital and Medical Center
		Ivor Benjamin	Ph: 623-773-2873
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Susan Davidson	Ph: 720-848-0650
	Fort Collins
	Front Range Cancer Specialists
		Diana C. Medgyesy	Ph: 970-212-7600
	Poudre Valley Hospital
		Paolo Romero	Ph: 970-495-8226
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
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		James E Kendrick	Ph: 407-303-5623
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Seiko Diane Yamada	Ph: 773-834-7424
	Eureka
	Eureka Community Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Havana
	Illinois CancerCare - Havana
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Hinsdale
	Gynecologic Oncology
		Sudarshan K. Sharma	Ph: 630-856-6757
	Normal
	BroMenn Regional Medical Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Community Cancer Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Spring Valley
	Illinois CancerCare - Spring Valley
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
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
	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
	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
	Clive
	Medical Oncology and Hematology Associates-West Des Moines
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Mercy Cancer Center - West Lakes
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	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
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Bruce Wender	Ph: 712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
	St. Luke's Regional Medical Center
		Donald Bruce Wender	Ph: 712-252-0088
	West Des Moines
	Methodist West Hospital
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
Kentucky
	Edgewood
	St. Elizabeth Medical Center
		Jack Basil	Ph: 859-301-5473
			Email: darla.hehman@stelizabeth.com
	Lexington
	University of Kentucky Chandler Medical Center
		Frederick Ueland	Ph: 859-257-3379
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Paul Celano	Ph: 443-849-3706
	Elkton MD
	Union Hospital of Cecil County
		Mark E Borowsky	Ph: 302-733-6227
Michigan
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Jonathan E Tammela	Ph: 920-433-8889
	Iron Mountain
	Green Bay Oncology - Iron Mountain
		Jonathan E Tammela	Ph: 920-433-8889
	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
	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
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		James Tate Thigpen	Ph: 601-815-6700
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David Gardner Mutch	Ph: 800-600-3606
			Email: info@ccadmin.wustl.edu
Montana
	Billings
	Billings Clinic Cancer Center - 801 N 29th Street
		Benjamin Thomas Marchello	Ph: 800-648-6274
	CCOP - Montana Cancer Consortium
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Thomas Marchello	Ph: 800-648-6274
	St. Vincent Healthcare Cancer Care Services
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Butte
	St. James Healthcare Cancer Care
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Great Falls
	Benefis Sletten Cancer Institute
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Helena
	St. Peter's Hospital
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Kalispell
	Kalispell Regional Medical Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Montana Cancer Specialists at Montana Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
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
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		David P. Warshal	Ph: 856-325-6757
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
North Carolina
	Durham
	Duke Cancer Institute
		Angeles Alvarez Secord	Ph: 888-275-3853
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James N. Atkins	Ph: 919-580-0000
North Dakota
	Bismarck
	Medcenter One Hospital Cancer Care Center
		John T Reynolds	Ph: 701-323-5760
			Email: tfischer@mohs.org
	Mid Dakota Clinic, PC
		Edward J. Wos	Ph: 701-323-5760
			Email: tfischer@mohs.org
	St. Alexius Medical Center Cancer Center
		Edward J. Wos	Ph: 701-323-5760
			Email: tfischer@mohs.org
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Vivian von Gruenigen	Ph: 330-375-6101
	Chillicothe
	Adena Regional Medical Center
		J. Philip Kuebler	Ph: 502-361-8496
	Cincinnati
	Good Samaritan Hospital Cancer Treatment Center
		Jack Basil	Ph: 859-301-5473
			Email: darla.hehman@stelizabeth.com
	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
	CCOP - Columbus
		J. Philip Kuebler	Ph: 502-361-8496
	Doctors Hospital at Ohio Health
		J. Philip Kuebler	Ph: 502-361-8496
	Grant Medical Center Cancer Care
		J. Philip Kuebler	Ph: 502-361-8496
	Mount Carmel Health - West Hospital
		J. Philip Kuebler	Ph: 502-361-8496
	Riverside Methodist Hospital Cancer Care
		Jeffrey G. Bell	Ph: 614-566-4475
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler	Ph: 502-361-8496
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler	Ph: 502-361-8496
	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
	Mount Vernon
	Knox Community Hospital
		J. Philip Kuebler	Ph: 502-361-8496
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler	Ph: 502-361-8496
	Portsmouth
	Southern Ohio Medical Center Cancer Center
		J. Philip Kuebler	Ph: 502-361-8496
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler	Ph: 502-361-8496
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler	Ph: 502-361-8496
	Zanesville
	Genesis - Good Samaritan Hospital
		J. Philip Kuebler	Ph: 502-361-8496
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
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		Nicholas P Taylor	Ph: 610-954-3582
			Email: infolink@slhn.org
	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
	State College
	Geisinger Medical Group - Scenery Park
		James R Bosscher	Ph: 570-271-5251
			Email: ehicks@sprg.mercy.net
	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
		Carolyn K McCourt	Ph: 401-274-1122
South Carolina
	Anderson
	AnMed Cancer Center
		David Griffin	Ph: 864-512-1000
	Spartanburg
	CCOP - Upstate Carolina
		David Griffin	Ph: 864-512-1000
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		David Griffin	Ph: 864-512-1000
Texas
	Houston
	Methodist Hospital
		Aparna A Kamat	Ph: 281-277-5200
	Univeristy of Texas M.D. Anderson Cancer Center
		Michael M Frumovitz	Ph: 713-792-3245
Virginia
	Danville
	Danville Regional Medical Center
		Timothy W. Brotherton	Ph: 434-793-0044
	Lynchburg
	Lynchburg Hematology-Oncology Clinic
		John Leach MacNeill	Ph: 434-200-5925
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. Mary's Hospital Medical Center - Green Bay
		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
		Kurt Oettel	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Manitowoc
	Holy Family Memorial Medical Center Cancer Care Center
		Jonathan E Tammela	Ph: 920-433-8889
	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
	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
		Scott A Kamelle	Ph: 414-649-7200
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Jonathan E Tammela	Ph: 920-433-8889
	Sheboygan
	Vince Lombardi Cancer Clinic - Sheboygan
		Santhosh Kumar	Ph: 414-649-7200
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Jonathan E Tammela	Ph: 920-433-8889
	Summit
	Aurora Medical Center
		Ali Mahdavi	Ph: 414-649-5717
			Email: ucstudy@uci.edu
	West Allis
	Aurora Women's Pavilion of West Allis Memorial Hospital
		Peter Johnson	Ph: 800-252-2990
Wyoming
	Casper
	Rocky Mountain Oncology
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Thomas Marchello	Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01081262
Information obtained from ClinicalTrials.gov on February 05, 2013

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