Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer
- Interventions
- Registration Number
- NCT00028743
- Lead Sponsor
- NCIC Clinical Trials Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 819
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cisplatin, Topotecan, Paclitaxel plus Carboplatin carboplatin Arm 1 Cisplatin, Topotecan, Paclitaxel plus Carboplatin cisplatin Arm 1 Cisplatin, Topotecan, Paclitaxel plus Carboplatin topotecan hydrochloride Arm 1 Paclitaxel plus Carboplatin carboplatin Arm 2 Paclitaxel plus Carboplatin paclitaxel Arm 2 Cisplatin, Topotecan, Paclitaxel plus Carboplatin paclitaxel Arm 1
- Primary Outcome Measures
Name Time Method Progression free survival Mar 2008
- Secondary Outcome Measures
Name Time Method Overall Survival Dec 2012 Response Rates March 2008 Toxic Effects March 2008 Quality of Life March 2008 CA125 Normalization Rates March 2008
Related Research Topics
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Trial Locations
- Locations (28)
Lions Gate Hospital
🇨🇦North Vancouver, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
Ottawa Health Research Institute - General Division
🇨🇦Ottawa, Ontario, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Grand River Regional Cancer Centre
🇨🇦Kitchener, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
Northeast Cancer Center Health Sciences
🇨🇦Sudbury, Ontario, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
🇨🇦Charlottetown, Prince Edward Island, Canada
Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Thunder Bay Regional Health Science Centre
🇨🇦Thunder Bay, Ontario, Canada