Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
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
6 other identifiers
interventional
N/A
2 countries
74
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 1999
Typical duration for phase_3 ovarian-cancer
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 6, 2000
CompletedFirst Posted
Study publicly available on registry
July 28, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedDecember 23, 2015
December 1, 2015
7.1 years
November 6, 2000
December 22, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- AGO Study Grouplead
- European Organisation for Research and Treatment of Cancer - EORTCcollaborator
- NCIC Clinical Trials Groupcollaborator
Study Sites (74)
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7, Canada
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, V6Z 1Y6, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5, Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1PS, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2, Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, L8N 1T8, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
Grand River Regional Cancer Centre
Kitchner, Ontario, N2G 1G3, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Markham Stouffville Hospital
Markham, Ontario, L3P 7T3, Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8, Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
York County Hospital
Newmarket, Ontario, L3Y 2P9, Canada
North York General Hospital, Ontario
North York, Ontario, M2E 1K1, Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, L6H 3PI, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6, Canada
Algoma District Medical Group
Sault Ste. Marie, Ontario, P6B 1Y5, Canada
Scarborough Hospital - General Site
Scarborough Village, Ontario, M1P 2V5, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, M5S 1B6, Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5, Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5, Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, G7H 5H6, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, J6E 6J2, Canada
L'Hotel Dieu de Levis
Lévis, Quebec, G6V 3Z1, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, H2W 1T8, Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8, Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, H9R 4S3, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6, Canada
Hopital du Saint-Sacrament, Quebec
Québec, Quebec, G1S 4L8, Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, G5L 5T1, Canada
L'Hopital Laval
Ste-Foy, Quebec, G1V 4G5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Lions Gate Hospital
North Vancouver, V7L 2P9, Canada
Toronto Urology Study Group
Toronto, M6A 3B5, Canada
Related Publications (5)
Pfisterer J, Plante M, Vergote I, et al.: Gemcitabine/carboplatin (GC) vs. carboplatin (C) in platinum sensitive recurrent ovarian cancer (OVCA). Results of a Gynecologic Cancer Intergroup randomized phase III trial of the AGO OVAR, the NCIC CTG and the EORTC GCG. [Abstract] J Clin Oncol 22 (14 Suppl): A-5005, 450s, 2004.
RESULTPfisterer J, Vergote I, Du Bois A, Eisenhauer E; AGO-OVAR,; NCIC CTG; EORTC GCG. Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer. Int J Gynecol Cancer. 2005 May-Jun;15 Suppl 1:36-41. doi: 10.1111/j.1525-1438.2005.15355.x.
PMID: 15839957RESULTVergote I, Plante M, Richter B, et al.: Improved progression free survival (PFS) and quality of life (QOL) in a randomised study comparing gemcitabine/carboplatinum (GC) vs. carboplatin (C) in platinum sensitive ovarian cancer (OVCA). [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-155, 45, 2004.
RESULTKurzeder C, Zhao L, Eisenhauer EA, et al.: The impact of dose intensity on the efficacy of gemcitabine plus carboplatin (GC) therapy for recurrent platinum-sensitive ovarian cancer (PSOC): A retrospective analysis of AGO-OVAR 2.5. [Abstract] J Clin Oncol 29 (Suppl 15): A-5088, 2011.
RESULTPfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stahle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Luck HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006 Oct 10;24(29):4699-707. doi: 10.1200/JCO.2006.06.0913. Epub 2006 Sep 11.
PMID: 16966687RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jacobus Pfisterer, MD
University Hospital Schleswig-Holstein
- STUDY CHAIR
Angel J. Lacave, MD, PhD
Hospital Universitario Central de Asturias
- STUDY CHAIR
Marie Plante, MD
Centre Hospitalier Universitaire de Quebec
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2000
First Posted
July 28, 2003
Study Start
September 1, 1999
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
December 23, 2015
Record last verified: 2015-12