Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
- Conditions
- Fallopian Tube CancerOvarian Cancer
- Interventions
- Drug: TCDrug: TCG
- Registration Number
- NCT00052468
- Lead Sponsor
- AGO Study 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 may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.
- Detailed Description
OBJECTIVES:
* Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.
* Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.
* Compare toxic effects of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
* Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.
Some patients undergo interval debulking surgery.
Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.
Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1742
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description TC TC Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses TCG TCG Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
- Primary Outcome Measures
Name Time Method Overall Survival Whole Study Period Survival time is calculated from the date of enrollment into the study until the date of death from any cause
- Secondary Outcome Measures
Name Time Method Progression Free Survival Whole Study Period The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first
Trial Locations
- Locations (17)
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Evangelisches Krankenhaus
🇩🇪Dusseldorf, Germany
Zentralkrankenhaus
🇩🇪Bremen, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Copenhagen, Denmark
Hotel Dieu de Paris
🇫🇷Paris, France
Staedtische Kliniken Frankfurt am Main - Hoechst
🇩🇪Frankfurt, Germany
Frauenklinik der MHH
🇩🇪Hannover, Germany
Vincentius Krankenhaus
🇩🇪Karlsruhe, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
🇩🇪Munich, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitaet Ulm
🇩🇪Ulm, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Norwegian Radium Hospital
🇳🇴Oslo, Norway