Ovarian Cancer Clinical Trial

Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Ovarian Cancer

Phase:

Phase 3

Study ID:

NCT00006453

Recruitment Status:

Completed

Sponsor:

AGO Study Group

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There are 70 Locations for this study

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St. Mary's/Duluth Clinic Health System
Duluth Minnesota, 55805, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Lethbridge Cancer Clinic
Lethbridge Alberta, T1J 1, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna British Columbia, V1Y 5, Canada
Nanaimo Cancer Clinic
Nanaimo British Columbia, V9S 2, Canada
Penticton Regional Hospital
Penticton British Columbia, V2A 3, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey British Columbia, V3V 1, Canada
Prostate Centre at Vancouver General Hospital
Vancouver British Columbia, V5Z 3, Canada
British Columbia Cancer Agency
Vancouver British Columbia, V5Z 4, Canada
St. Paul's Hospital - Vancouver
Vancouver British Columbia, V6Z 1, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria British Columbia, V8R 6, Canada
G. Steinhoff Clinical Research
Victoria British Columbia, V8V 3, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Moncton Hospital
Moncton New Brunswick, E1C 6, Canada
Doctor Leon Richard Oncology Centre
Moncton New Brunswick, E1C 8, Canada
Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns Newfoundland and Labrador, A1B 3, Canada
Nova Scotia Cancer Centre
Halifax Nova Scotia, B3H 1, Canada
Cape Breton Cancer Centre
Sydney Nova Scotia, B1P 1, Canada
Royal Victoria Hospital, Barrie
Barrie Ontario, L4M 6, Canada
William Osler Health Centre
Brampton Ontario, L6W 2, Canada
Hamilton and Disrict Urology Association
Hamilton Ontario, L8N 1, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton Ontario, L8V 5, Canada
Kingston Regional Cancer Centre
Kingston Ontario, K7L 5, Canada
Grand River Regional Cancer Centre
Kitchner Ontario, N2G 1, Canada
London Health Sciences Centre
London Ontario, N6A 4, Canada
Cancer Care Ontario-London Regional Cancer Centre
London Ontario, N6A 4, Canada
Markham Stouffville Hospital
Markham Ontario, L3P 7, Canada
Trillium Health Centre
Mississauga Ontario, L5B 1, Canada
Credit Valley Hospital
Mississauga Ontario, L5M 2, Canada
York County Hospital
Newmarket Ontario, L3Y 2, Canada
North York General Hospital, Ontario
North York Ontario, M2E 1, Canada
Male Health Centre/CMX Research Inc.
Oakville Ontario, L6H 3, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
Ottawa Regional Cancer Centre
Ottawa Ontario, K1H 1, Canada
Peterborough Oncology Clinic
Peterborough Ontario, K9H 7, Canada
Algoma District Medical Group
Sault Sainte Marie Ontario, P6B 1, Canada
Scarborough Hospital - General Site
Scarborough Ontario, M1P 2, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines Ontario, L2R 5, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury Ontario, P3E 5, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay Ontario, P7A 7, Canada
Toronto East General Hospital
Toronto Ontario, M4C 3, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada
St. Michael's Hospital - Toronto
Toronto Ontario, M5B 1, Canada
Mount Sinai Hospital - Toronto
Toronto Ontario, M5G 1, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto Ontario, M5S 1, Canada
Saint Joseph's Health Centre - Toronto
Toronto Ontario, M6R 1, Canada
Humber River Regional Hospital
Weston Ontario, M9N 1, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor Ontario, N8W 2, Canada
Queen Elizabeth Hospital, PEI
Charlottetown Prince Edward Island, C1A 8, Canada
Complexe Hospitalier de la Sagamie
Chicoutimi Quebec, G7H 5, Canada
CHUS-Hopital Fleurimont
Fleurimont Quebec, J1H 5, Canada
Hopital Charles Lemoyne
Greenfield Park Quebec, J4V 2, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette Quebec, J6E 6, Canada
L'Hotel Dieu de Levis
Levis Quebec, G6V 3, Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec, H1T 2, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2L-4, Canada
McGill University
Montreal Quebec, H2W 1, Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal Quebec, H2W 1, Canada
Hotel Dieu de Montreal
Montreal Quebec, H2W 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal Quebec, H4J 1, Canada
Kells Medical Research Group Inc.
Pointe Claire Quebec, H9R 4, Canada
Centre Hospitalier Universitaire de Quebec
Quebec City Quebec, G1R 2, Canada
Hopital du Saint-Sacrament, Quebec
Quebec City Quebec, G1S 4, Canada
Centre Hospitalier Regional de Rimouski
Rimouski Quebec, G5L 5, Canada
L'Hopital Laval
Ste-Foy Quebec, G1V 4, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Lions Gate Hospital
North Vancouver , V7L 2, Canada
Toronto Urology Study Group
Toronto , M6A 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Study ID:

NCT00006453

Recruitment Status:

Completed

Sponsor:


AGO Study Group

How clear is this clinincal trial information?

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