- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006453
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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North Vancouver, Canada, V7L 2P9
- Lions Gate Hospital
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Toronto, Canada, M6A 3B5
- Toronto Urology Study Group
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Lethbridge, Alberta, Canada, T1J 1W5
- Lethbridge Cancer Clinic
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- British Columbia Cancer Agency - Centre for the Southern Interior
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Nanaimo, British Columbia, Canada, V9S 2B7
- Nanaimo Cancer Clinic
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Penticton, British Columbia, Canada, V2A 3G6
- Penticton Regional Hospital
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Surrey, British Columbia, Canada, V3V 1Z2
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
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Vancouver, British Columbia, Canada, V5Z 3J5
- Prostate Centre at Vancouver General Hospital
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital - Vancouver
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Victoria, British Columbia, Canada, V8V 3N1
- G. Steinhoff Clinical Research
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Victoria, British Columbia, Canada, V8R 6V5
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6ZB
- Moncton Hospital
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Moncton, New Brunswick, Canada, E1C 8X3
- Doctor Leon Richard Oncology Centre
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Sydney, Nova Scotia, Canada, B1P 1PS
- Cape Breton Cancer Centre
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Royal Victoria Hospital, Barrie
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Brampton, Ontario, Canada, L6W 2Z8
- William Osler Health Centre
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Hamilton, Ontario, Canada, L8N 1T8
- Hamilton and Disrict Urology Association
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
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Kitchner, Ontario, Canada, N2G 1G3
- Grand River Regional Cancer Centre
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London, Ontario, Canada, N6A 4G5
- London Health Sciences Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Markham, Ontario, Canada, L3P 7T3
- Markham Stouffville Hospital
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Mississauga, Ontario, Canada, L5B 1B8
- Trillium Health Centre
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital
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Newmarket, Ontario, Canada, L3Y 2P9
- York County Hospital
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North York, Ontario, Canada, M2E 1K1
- North York General Hospital, Ontario
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Oakville, Ontario, Canada, L6H 3PI
- Male Health Centre/CMX Research Inc.
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health Oshawa
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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Peterborough, Ontario, Canada, K9H 7B6
- Peterborough Oncology Clinic
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Sault Sainte Marie, Ontario, Canada, P6B 1Y5
- Algoma District Medical Group
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Scarborough, Ontario, Canada, M1P 2V5
- Scarborough Hospital - General Site
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St. Catharines, Ontario, Canada, L2R 5K3
- Hotel Dieu Health Sciences Hospital - Niagara
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canada, M4C 3E7
- Toronto East General Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital - Toronto
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital - Toronto
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Toronto, Ontario, Canada, M5S 1B6
- Women's College Campus, Sunnybrook and Women's College Health Science Center
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Toronto, Ontario, Canada, M6R 1B5
- Saint Joseph's Health Centre - Toronto
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Weston, Ontario, Canada, M9N 1N8
- Humber River Regional Hospital
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Windsor, Ontario, Canada, N8W 2X3
- Cancer Care Ontario - Windsor Regional Cancer Centre
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 8T5
- Queen Elizabeth Hospital, PEI
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Complexe Hospitalier de la Sagamie
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Greenfield Park, Quebec, Canada, J4V 2H1
- Hopital Charles Lemoyne
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Joliette, Quebec, Canada, J6E 6J2
- Centre Hospitalier Régional de Lanaudière
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Levis, Quebec, Canada, G6V 3Z1
- L'Hotel Dieu de Levis
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Montreal, Quebec, Canada, H2W 1T8
- Centre Hospitalier de l'Universite' de Montreal
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Montreal, Quebec, Canada, H2W 1T8
- Hotel Dieu de Montreal
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Montreal, Quebec, Canada, H4J 1C5
- Hopital du Sacre-Coeur de Montreal
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Montreal, Quebec, Canada, H3T 1C5
- Hopital Sainte Justine
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Montreal, Quebec, Canada, H2L-4M1
- Centre Hospitalier de l'Université de Montréal
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Pointe Claire, Quebec, Canada, H9R 4S3
- Kells Medical Research Group Inc.
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Quebec City, Quebec, Canada, G1S 4L8
- Hopital du Saint-Sacrament, Quebec
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Rimouski, Quebec, Canada, G5L 5T1
- Centre Hospitalier Regional De Rimouski
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Ste-Foy, Quebec, Canada, G1V 4G5
- L'Hopital Laval
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Minnesota
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Duluth, Minnesota, United States, 55805
- St. Mary's/Duluth Clinic Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy
- Evidence of recurrence or progression 6 months after discontinuation of prior first-line platinum-containing regimen
- No tumor of borderline malignancy
- Evaluable disease outside previously irradiated area
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Not specified
Renal:
- Glomerular filtration rate greater than 50 mL/min
Other:
- No concurrent active infection
- No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
- No other concurrent serious systemic disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No more than 1 prior platinum-based chemotherapy regimen
- No prior gemcitabine
- No other concurrent cytotoxic or antineoplastic treatment
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy
- Concurrent hormone replacement therapy allowed
- Concurrent steroid antiemetics allowed
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy (limited to the small pelvis)
- Concurrent palliative radiotherapy to nontarget lesions allowed
Surgery:
- See Disease Characteristics
Other:
- At least 3 weeks since other prior investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- Pfisterer 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.
- Vergote 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.
- Kurzeder 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.
- Pfisterer 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067993
- AGOSG-OVAR-2.5
- CAN-NCIC-OV15
- EORTC-55005
- EU-20064
- NCI-V00-1601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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