Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
OBJECTIVES:
- Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal
radiotherapy in patients with stage III or IV endometrial cancer.
- Determine the acute and chronic toxic effects, in particular, severe and
life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this
regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks
for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6
weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Jeffrey M. Fowler, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Federal Government
CDR0000067844
NCT00005830
July 2000
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |