Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00006453
- Lead Sponsor
- AGO Study Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.
- Detailed Description
OBJECTIVES:
* Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine.
* Compare response rate, duration of response, and survival time of patients treated with these regimens.
* Compare the toxicity of these treatment regimens in these patients.
* Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
* Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.
Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
G. Steinhoff Clinical Research
🇨🇦Victoria, British Columbia, Canada
William Osler Health Centre
🇨🇦Brampton, Ontario, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
York County Hospital
🇨🇦Newmarket, Ontario, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto
🇨🇦Toronto, Ontario, Canada
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Complexe Hospitalier de la Sagamie
🇨🇦Chicoutimi, Quebec, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere
🇨🇦Joliette, Quebec, Canada
Hopital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
L'Hotel Dieu de Levis
🇨🇦Levis, Quebec, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite' de Montreal
🇨🇦Montreal, Quebec, Canada
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Grand River Regional Cancer Centre
🇨🇦Kitchner, Ontario, Canada
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Lethbridge Cancer Clinic
🇨🇦Lethbridge, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
Hamilton and Disrict Urology Association
🇨🇦Hamilton, Ontario, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
North York General Hospital, Ontario
🇨🇦North York, Ontario, Canada
Male Health Centre/CMX Research Inc.
🇨🇦Oakville, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre
🇨🇦Sydney, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Algoma District Medical Group
🇨🇦Sault Sainte Marie, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Peterborough Oncology Clinic
🇨🇦Peterborough, Ontario, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
Hotel Dieu de Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Kells Medical Research Group Inc.
🇨🇦Pointe Claire, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Lions Gate Hospital
🇨🇦North Vancouver, Canada
Hopital Du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Toronto Urology Study Group
🇨🇦Toronto, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Nanaimo Cancer Clinic
🇨🇦Nanaimo, British Columbia, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Centre Hospitalier Regional de Rimouski
🇨🇦Rimouski, Quebec, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
🇨🇦Quebec City, Quebec, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
🇨🇦Toronto, Ontario, Canada
Scarborough Hospital - General Site
🇨🇦Scarborough, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Markham Stouffville Hospital
🇨🇦Markham, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
🇨🇦St. Catharines, Ontario, Canada