Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
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|ClinicalTrials.gov Identifier: NCT00003334|
Recruitment Status : Completed
First Posted : February 9, 2004
Last Update Posted : March 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma||Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin|
|Study Start Date :||March 1997|
|Actual Primary Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003334
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|Study Chair:||Franco M. Muggia, MD||NYU Langone Health|