Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin
OBJECTIVES: I. Determine the response rate and duration of response to doxorubicin HCl
liposome and paclitaxel in patients with endometrial cancer, tubal cancers, and sarcomas and
carcinosarcomas (mixed mesodermal tumors) of gynecologic origin. II. Define the safety
profile of the combination of doxorubicin HCl liposome and paclitaxel in this patient
OUTLINE: Patients are stratified into two groups. Group 1 consists of patients with
untreated endometrial and tubal cancers and Group 2 consists of patients with sarcomas and
carcinosarcomas (mixed mesodermal tumors) of gynecologic origin subdivided into no or prior
therapy. Patients receive doxorubicin HCl liposome intravenously on day 1 of each treatment
course. Paclitaxel is administered intravenously weekly on days 1, 8, and 15 of each course.
Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic
effects or disease progression. Patients are followed every 3 months for 2 years, then every
6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 28-60 patients will be accrued for this study.
Primary Purpose: Treatment
Franco M. Muggia, MD
New York University School of Medicine
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|Mount Sinai Medical Center, NY||New York, New York 10029|
|New York Presbyterian Hospital - Cornell Campus||New York, New York 10021|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|
|New York Medical College||Valhalla, New York 10595|