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| Sponsor: | AGO Ovarian Cancer Study Group |
|---|---|
| Collaborators: |
European Organization for Research and Treatment of Cancer NCIC Clinical Trials Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006453 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy |
| Study Start Date: | September 1999 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Minnesota | |
| St. Mary's/Duluth Clinic Health System | |
| Duluth, Minnesota, United States, 55805 | |
| Canada | |
| Lions Gate Hospital | |
| North Vancouver, Canada, V7L 2P9 | |
| Toronto Urology Study Group | |
| Toronto, Canada, M6A 3B5 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Lethbridge Cancer Clinic | |
| Lethbridge, Alberta, Canada, T1J 1W5 | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| British Columbia Cancer Agency - Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| British Columbia Cancer Agency - Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| British Columbia Cancer Agency - Vancouver Island Cancer Centre | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| G. Steinhoff Clinical Research | |
| Victoria, British Columbia, Canada, V8V 3N1 | |
| Nanaimo Cancer Clinic | |
| Nanaimo, British Columbia, Canada, V9S 2B7 | |
| Penticton Regional Hospital | |
| Penticton, British Columbia, Canada, V2A 3G6 | |
| Prostate Centre at Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z 3J5 | |
| St. Paul's Hospital - Vancouver | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Doctor Leon Richard Oncology Centre | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Moncton Hospital | |
| Moncton, New Brunswick, Canada, E1C 6ZB | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Treatment and Research Foundation | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Cape Breton Cancer Centre | |
| Sydney, Nova Scotia, Canada, B1P 1PS | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Algoma District Medical Group | |
| Sault Sainte Marie, Ontario, Canada, P6B 1Y5 | |
| Cancer Care Ontario - Windsor Regional Cancer Centre | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Credit Valley Hospital | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Grand River Regional Cancer Centre | |
| Kitchner, Ontario, Canada, N2G 1G3 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Hotel Dieu Health Sciences Hospital - Niagara | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Humber River Regional Hospital | |
| Weston, Ontario, Canada, M9N 1N8 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Lakeridge Health Oshawa | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4G5 | |
| Male Health Centre/CMX Research Inc. | |
| Oakville, Ontario, Canada, L6H 3PI | |
| Markham Stouffville Hospital | |
| Markham, Ontario, Canada, L3P 7T3 | |
| Hamilton and Disrict Urology Association | |
| Hamilton, Ontario, Canada, L8N 1T8 | |
| North York General Hospital, Ontario | |
| North York, Ontario, Canada, M2E 1K1 | |
| Northeastern Ontario Regional Cancer Centre, Sudbury | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Northwestern Ontario Regional Cancer Centre, Thunder Bay | |
| Thunder Bay, Ontario, Canada, P7A 7T1 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Peterborough Oncology Clinic | |
| Peterborough, Ontario, Canada, K9H 7B6 | |
| St. Michael's Hospital - Toronto | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Royal Victoria Hospital, Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Saint Joseph's Health Centre - Toronto | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| Scarborough Hospital - General Site | |
| Scarborough, Ontario, Canada, M1P 2V5 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto East General Hospital | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Trillium Health Centre | |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| William Osler Health Centre | |
| Brampton, Ontario, Canada, L6W 2Z8 | |
| Women's College Campus, Sunnybrook and Women's College Health Science Center | |
| Toronto, Ontario, Canada, M5S 1B6 | |
| York County Hospital | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Canada, Prince Edward Island | |
| Queen Elizabeth Hospital, PEI | |
| Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L-4M1 | |
| Centre Hospitalier de l'Universite' de Montreal | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Centre Hospitalier Regional de Lanaudiere | |
| Joliette, Quebec, Canada, J6E 6J2 | |
| Centre Hospitalier Regional de Rimouski | |
| Rimouski, Quebec, Canada, G5L 5T1 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| CHUS-Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Hopital du Saint-Sacrament, Quebec | |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Hopital Du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Complexe Hospitalier de la Sagamie | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Hotel Dieu de Montreal | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Kells Medical Research Group Inc. | |
| Pointe Claire, Quebec, Canada, H9R 4S3 | |
| L'Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| L'Hotel Dieu de Levis | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Study Chair: | Jacobus Pfisterer, MD | University Hospital Schleswig-Holstein - Kiel Campus |
| Study Chair: | Angel J. Lacave, MD, PhD | Hospital Universitario Central de Asturias |
| Study Chair: | Marie Plante, MD | Centre Hospitalier Universitaire de Quebec |
More Information
| Study ID Numbers: | CDR0000067993, AGOSG-OVAR-2.5, CAN-NCIC-OV15, EORTC-55005, EU-20064, NCI-V00-1601 |
| Study First Received: | November 6, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006453 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses |
Gemcitabine Endocrine Gland Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents |