Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
NCT ID: NCT00006453
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1999-09-30
2006-10-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
NCIC Clinical Trials Group
NETWORK
AGO Study Group
OTHER
Responsible Party
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Principal Investigators
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Jacobus Pfisterer, MD
Role: STUDY_CHAIR
University Hospital Schleswig-Holstein
Angel J. Lacave, MD, PhD
Role: STUDY_CHAIR
Hospital Universitario Central de Asturias
Marie Plante, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire de Quebec
Locations
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St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchner, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
York County Hospital
Newmarket, Ontario, Canada
North York General Hospital, Ontario
North York, Ontario, Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, Canada
Algoma District Medical Group
Sault Ste. Marie, Ontario, Canada
Scarborough Hospital - General Site
Scarborough Village, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
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
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada
L'Hotel Dieu de Levis
Lévis, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada
Hotel Dieu de Montreal
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
Québec, Quebec, Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Lions Gate Hospital
North Vancouver, , Canada
Toronto Urology Study Group
Toronto, , Canada
Countries
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References
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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.
Other Identifiers
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AGOSG-OVAR-2.5
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-OV15
Identifier Type: -
Identifier Source: secondary_id
EORTC-55005
Identifier Type: -
Identifier Source: secondary_id
EU-20064
Identifier Type: -
Identifier Source: secondary_id
NCI-V00-1601
Identifier Type: -
Identifier Source: secondary_id
CDR0000067993
Identifier Type: -
Identifier Source: org_study_id