Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer
- Compare the overall survival of patients with locally advanced, metastatic, and/or
relapsed endometrial cancer treated with doxorubicin and cisplatin with or without
- Compare the toxicity of these regimens in these patients.
- Compare the progression-free survival at 18 months of patients treated with these
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic
radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and
cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I. Quality of life is
assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2
years, every 6 months for 3 years, and then annually thereafter. In the event of
progressive disease, quality of life is assessed every 3 months.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter. In the event of progressive disease, patients are followed every 3
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival as measured by Kaplan Meier and RECIST at 18 months
Nicholas S. Reed, MD
University of Glasgow
United States: Federal Government