Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract

Phase 2

Completed

• Conditions: Endometrial Cancer; Sarcoma; Ovarian Cancer; Fallopian Tube Cancer

• Registration Number: NCT00003334
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1997-03
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-12
• Study First Submitted QC: 2004-02-06
• Study First Posted: 2004-02-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States

Albert Einstein Comprehensive Cancer Center; 🇺🇸 Bronx, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Mount Sinai Medical Center, NY; 🇺🇸 New York, New York, United States

New York Medical College; 🇺🇸 Valhalla, New York, United States