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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 70 Locations for this study
Duluth Minnesota, 55805, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Lethbridge Alberta, T1J 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Nanaimo British Columbia, V9S 2, Canada
Penticton British Columbia, V2A 3, Canada
Surrey British Columbia, V3V 1, Canada
Vancouver British Columbia, V5Z 3, Canada
Vancouver British Columbia, V5Z 4, Canada
Vancouver British Columbia, V6Z 1, Canada
Victoria British Columbia, V8R 6, Canada
Victoria British Columbia, V8V 3, Canada
Winnipeg Manitoba, R3E 0, Canada
Moncton New Brunswick, E1C 6, Canada
Moncton New Brunswick, E1C 8, Canada
Saint John New Brunswick, E2L 4, Canada
St. Johns Newfoundland and Labrador, A1B 3, Canada
Halifax Nova Scotia, B3H 1, Canada
Sydney Nova Scotia, B1P 1, Canada
Barrie Ontario, L4M 6, Canada
Brampton Ontario, L6W 2, Canada
Hamilton Ontario, L8N 1, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 5, Canada
Kitchner Ontario, N2G 1, Canada
London Ontario, N6A 4, Canada
London Ontario, N6A 4, Canada
Markham Ontario, L3P 7, Canada
Mississauga Ontario, L5B 1, Canada
Mississauga Ontario, L5M 2, Canada
Newmarket Ontario, L3Y 2, Canada
North York Ontario, M2E 1, Canada
Oakville Ontario, L6H 3, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 1, Canada
Peterborough Ontario, K9H 7, Canada
Sault Sainte Marie Ontario, P6B 1, Canada
Scarborough Ontario, M1P 2, Canada
St. Catharines Ontario, L2R 5, Canada
Sudbury Ontario, P3E 5, Canada
Thunder Bay Ontario, P7A 7, Canada
Toronto Ontario, M4C 3, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5B 1, Canada
Toronto Ontario, M5G 1, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5S 1, Canada
Toronto Ontario, M6R 1, Canada
Weston Ontario, M9N 1, Canada
Windsor Ontario, N8W 2, Canada
Charlottetown Prince Edward Island, C1A 8, Canada
Chicoutimi Quebec, G7H 5, Canada
Fleurimont Quebec, J1H 5, Canada
Greenfield Park Quebec, J4V 2, Canada
Joliette Quebec, J6E 6, Canada
Levis Quebec, G6V 3, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2L-4, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4J 1, Canada
Pointe Claire Quebec, H9R 4, Canada
Quebec City Quebec, G1R 2, Canada
Quebec City Quebec, G1S 4, Canada
Rimouski Quebec, G5L 5, Canada
Ste-Foy Quebec, G1V 4, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
North Vancouver , V7L 2, Canada
Toronto , M6A 3, Canada
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.