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Last Modified: 1/4/2009     First Published: 9/1/2000  
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Phase II Study of Paclitaxel in Patients With Ovarian Stromal Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase II
Treatment
Active
Not specified
NCI
GOG-0187
NCT00006227

Objectives

  1. Determine the clinical response to paclitaxel in patients with ovarian stromal cancer.
  2. Determine toxicity of this drug in these patients.
  3. Determine the value of inhibin for predicting response in these patients when treated with this regimen.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed ovarian stromal cancer not amenable to surgery
    • Granulosa cell tumor
    • Granulosa cell theca cell tumor
    • Sertoli-Leydig cell tumor (androblastoma)
    • Gynandroblastoma
    • Unclassified sex cord stromal tumor
    • Sex cord tumor with annular tubules
    • Steroid (lipid) cell tumor


  • Recurrent disease after no more than 1 prior chemotherapy regimen


  • Measurable disease
    • At least 1 cm in diameter


Prior/Concurrent Therapy:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to study lesion

Surgery:

  • See Disease Characteristics

Patient Characteristics:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm3
  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer

Expected Enrollment

45

A total of 45 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Frequency of complete clinical response

Secondary Outcome(s)

Duration of progression-free survival
Overall survival

Outline

This is a multicenter study. Patients are stratified according to prior treatment (yes vs no).

Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Howard Homesley, MD, Protocol chair
Ph: 252-756-5388
Email: hdh7173@aol.com

Trial Sites

U.S.A.
Alabama
  Birmingham
 Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
 Clinical Trials Office - Lurleen Wallace Comprehensive Cancer
Ph: 205-934-0309
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Clinical Trials Office - Helen and Harry Gray Cancer Center
Ph: 860-545-5363
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Clinical Trials Office - George Bray Cancer Center
Ph: 860-224-5660
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
Florida
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service
Ph: 866-574-5124
 Email: Sylvester@emergingmed.com
Georgia
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute
Ph: 912-350-8568
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3019
  Chicago
 Rush University Medical Center
 Clinical Trials Office - Rush University Medical Center
Ph: 312-942-5498
 Email: clinical_trials@rush.edu
 University of Illinois Cancer Center
 Clinical Trial Office - University of Illinois Cancer Center
Ph: 312-355-3046
  Hinsdale
 Hinsdale Hematology Oncology Associates
 Sudarshan Sharma, MD
Ph: 630-856-6757
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3019
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3019
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Cancer Information Service
Ph: 800-237-1225
Kentucky
  Lexington
 Lucille P. Markey Cancer Center at University of Kentucky
 Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center
Ph: 859-257-3379
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Clinical Trials Office - Louisville Oncology
Ph: 502-629-2500
Louisiana
  Baton Rouge
 Woman's Hospital
 Giles Fort, MD
Ph: 225-358-1071
Maryland
  Elkton MD
 Union Hospital Cancer Program at Union Hospital
 Mark Borowsky
Ph: 410-398-4000
Michigan
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7458
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 James Thigpen, MD
Ph: 601-984-5590
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Mutch, MD
Ph: 314-362-3181
New Jersey
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
New York
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine
Ph: 718-904-2730
 Email: aecc@aecom.yu.edu
  Brooklyn
 SUNY Downstate Medical Center
 Ovadia Abulafia, MD
Ph: 718-270-2152
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Clinical Trials Office - Lineberger Comprehensive Cancer Center
Ph: 877-668-0683; 919-966-4432
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884
  Durham
 Duke Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
Ph: 888-275-3853
Ohio
  Canton
 Aultman Cancer Center at Aultman Hospital
 Clinical Trials Office - Aultman Cancer Center at Aultman Hospital
Ph: 330-363-6891
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 William Richards
Ph: 806-796-1317
  Cleveland
 Cleveland Clinic Cancer Center at Fairview Hospital
 Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital
Ph: 216-476-9362
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Peter Rose, MD
Ph: 216-444-1712
  Columbus
 Mount Carmel Health - West Hospital
 George Lewandowski, MD
Ph: 614-224-7662
 Riverside Methodist Hospital Cancer Care
 Clinical Trials Office - Riverside Methodist Hospital Cancer Care
Ph: 614-566-4475
  Dayton
 David L. Rike Cancer Center at Miami Valley Hospital
 Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital
Ph: 937-208-2079
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Peter Rose, MD
Ph: 216-444-1712
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert Mannel, MD
Ph: 405-271-8787
  Tulsa
 Cancer Care Associates - Saint Francis Campus
 Robert Mannel, MD
Ph: 405-271-8787
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital
Ph: 215-481-2402
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Richard Boulay, MD
Ph: 610-402-3650
  Hershey
 Penn State Cancer Institute at Milton S. Hershey Medical Center
 Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center
Ph: 717-531-3779
 Email: CTO@hmc.psu.edu
  Philadelphia
 Fox Chase Cancer Center CCOP Research Base
 Clinical Trials Office - Fox Chase Cancer Center CCOP Research Base
Ph: 215-728-2983
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina
Ph: 843-792-9321
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Susan Modesitt
Ph: 434-924-9333
800-223-9173
Washington
  Seattle
 Fred Hutchinson Cancer Research Center
 Benjamin Greer, MD
Ph: 206-685-2463
  Tacoma
 Northwest Medical Specialties, PLLC - Tacoma
 Benjamin Greer, MD
Ph: 206-685-2463
Japan
  Kagoshima City, Kagoshima
 Kagoshima City Hospital
 Masayuki Hatae, MD
Ph: 81-99-224-2101
  Kure
 National Hospital Organization - Medical Center of Kure
 Kazuhiro Takehara
Ph: 81-82-322-3111
  Matsuyama
 Shikoku Cancer Center
 Masamichi Hiura, MD
Ph: 81-89-999-1111
  Osaka, Osaka
 Kinki University School of Medicine
 Yoh Watanabe
Ph: 81-723-66-0221
  Sapporo
 Hokkaido University Hospital
 Noriaki Sakuragi
Ph: 81-11-716-1161 ext. 6000
  Sendai
 Tohoku University Graduate School of Medicine
 Tadao Takano, MD
Ph: 81-22-717-7254
  Shinjuku-ku
 Keio University School of Medicine
 Nobuyuki Susumu, MD
Ph: 81-3-3353-1211ext.62275
  Tottori
 Tottori University Hospital
 Junzo Kigawa, MD, PhD
Ph: 81-859-33-1111
Iwate
  Morioka
 Iwate Medical University Hospital
 Toru Sugiyama
Ph: 81-19-651-5111

Registry Information
Official Title Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy
Trial Start Date 2000-11-20
Registered in ClinicalTrials.gov NCT00006227
Date Submitted to PDQ 2000-07-10
Information Last Verified 2009-01-04
NCI Grant/Contract Number CA27469

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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