Ovarian Cancer Clinical Trial
Official title:
Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and paclitaxel
in treating patients who have recurrent or refractory endometrial cancer, fallopian tube
cancer, or sarcoma of the female reproductive tract.
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
population.
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
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