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

Ovarian Cancer Clinical Trial

Official title:

Phase II Study of Doxil and Paclitaxel in Patients With Endometrial, Tubal, and Sarcomas of Gynecologic Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003334
• Other study ID #: CDR0000066300
• Secondary ID: NYU-9708NYGOG-NY
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 10, 2016
• Start date: March 1997

Study information

• Verified date: March 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Sarcoma

Intervention

Drug:
• paclitaxel

• pegylated liposomal doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Meeti