Spots Global Cancer Trial Database for Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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Trial Identification
Brief Title: Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Official Title: A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women With Newly Diagnosed Advanced Epithelial Ovarian Cancer
Study ID: NCT00028743
Study Description
Brief 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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.
Detailed Description: OBJECTIVES: * Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. * Compare the overall survival of patients treated with these regimens. * Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Compare the CA 125 normalization rates in patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms. * Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8. * Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4. Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
Lions Gate Hospital, North Vancouver, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
The Moncton Hospital, Moncton, New Brunswick, Canada
Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Center, Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Health Research Institute - General Division, Ottawa, Ontario, Canada
Niagara Health System, St. Catharines, Ontario, Canada
Northeast Cancer Center Health Sciences, Sudbury, Ontario, Canada
Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
PEI Cancer Treatment Centre,Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec, Quebec City, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Paul J. Hoskins, MD
Affiliation: British Columbia Cancer Agency
Role: STUDY_CHAIR
Name: Ignace B. Vergote, MD, PhD
Affiliation: University Hospital, Gasthuisberg
Role: STUDY_CHAIR
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