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

Primary Purpose

Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
pegylated liposomal doxorubicin hydrochloride
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring stage IV endometrial carcinoma, recurrent endometrial carcinoma, fallopian tube cancer, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma, ovarian sarcoma, ovarian carcinosarcoma

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory carcinoma of the endometrium or fallopian tubes or sarcomas of gynecologic origin including mixed mesodermal sarcomas Documented recurrence or persistence of disease after appropriate surgical and/or radiation therapy Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Granulocyte count at least 1,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 3 times ULN Renal: Creatinine less than 2.5 mg/dL Cardiovascular: MUGA at least lower limit of normal Normal ejection fraction and/or stable cardiac status Other: No medical or social factors that would interfere with compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent illness requiring immediate therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior combined modality or adjuvant chemotherapy Prior doxorubicin allowed if cumulative dose is recorded Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since prior noncytotoxic experimental antiemetic or antifungal investigational drugs

Sites / Locations

  • Albert Einstein Comprehensive Cancer Center
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • New York Presbyterian Hospital - Cornell Campus
  • Mount Sinai Medical Center, NY
  • New York Medical College

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 10, 2016
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003334
Brief Title
Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
Official Title
Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma
Keywords
stage IV endometrial carcinoma, recurrent endometrial carcinoma, fallopian tube cancer, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma, ovarian sarcoma, ovarian carcinosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory carcinoma of the endometrium or fallopian tubes or sarcomas of gynecologic origin including mixed mesodermal sarcomas Documented recurrence or persistence of disease after appropriate surgical and/or radiation therapy Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Granulocyte count at least 1,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 3 times ULN Renal: Creatinine less than 2.5 mg/dL Cardiovascular: MUGA at least lower limit of normal Normal ejection fraction and/or stable cardiac status Other: No medical or social factors that would interfere with compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent illness requiring immediate therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior combined modality or adjuvant chemotherapy Prior doxorubicin allowed if cumulative dose is recorded Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 30 days since prior noncytotoxic experimental antiemetic or antifungal investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco M. Muggia, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Hornreich G, Muggia FM, Wadler S, et al.: Phase II combination doxil-paclitaxel (PacliDox) in uterine carcinomas and sarcomas - an active regimen: a New York Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists 2003 Annual Meeting on Women's Cancer, January 31 - February 2, 2003, New Orleans, Louisiana. A-606, 2003.
Results Reference
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Learn more about this trial

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

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