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Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy Clinical research trials and Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy. Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy clinical trial. Test subjects typically receive the most expert healthcare available for their Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy  Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
For Condition: recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): AGO Ovarian Cancer Study Group , EORTC Gynecological Cancer Cooperative Group,National Cancer Institute of Canada
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Compare response rate, duration of response, and survival time of patients treated with these regimens. III. Compare the toxicity of these treatment regimens in these patients. IV. Compare quality of life of patients treated with these regimens. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndreasBois, Study Chair, AGO Ovarian Cancer Study Group
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, J6E 6J2
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
North York General Hospital, Ontario
North York, Ontario, M2E 1K1
Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, M5S 1B6
Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7
Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
York County Hospital
Newmarket, Ontario, L3Y 2P9
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5
Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Toronto Urology Study Group
Toronto, , M6A 3B5
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
United States
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, L6H 3PI
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Canada
Algoma District Medical Group
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
Canada
London Health Sciences Centre
London, Ontario, N6A 4G5
Canada
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, V6Z 1Y6
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1PS
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, G5L 5T1
Canada
Markham Stouffville Hospital
Markham, Ontario, L3P 7T3
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, H2W 1T8
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, G7H 5H6
Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
Scarborough Hospital - General Site
Scarborough, Ontario, M1P 2V5
Canada
Grand River Regional Cancer Centre
Kitchner, Ontario, N2G 1G3
Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, L8N 1T8
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, H9R 4S3
Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Canada
L'Hotel Dieu de Levis
Levis, Quebec, G6V 3Z1
Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Lions Gate Hospital
North Vancouver, , V7L 2P9
Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Additional Information:
Study ID Numbers: CDR0000067993; AGOSG-OVAR-2.5,EU-20064,NCI-V00-1601
Study Start Date: October 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006453
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
2. Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
3. Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer
4. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
5. Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other Alberta Clinical Trials
Other Lethbridge Clinical Trials
Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
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