A Multi-National Randomized Phase III GCIG Intergroup Study Comparing 1st Line Chemotherapy With Gemcitabine, Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV
- Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian
tube cancer treated with adjuvant carboplatin and paclitaxel with or without
- 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
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
PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for
this study within 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Andreas du Bois, MD, PhD
United States: Federal Government