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
- 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
PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this
study within 2 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Paul J. Hoskins, MD
British Columbia Cancer Agency
Canada: Health Canada