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	Treatment or Intervention	Phase
stage IV endometrial cancer stage IV uterine sarcoma uterine leiomyosarcoma Fallopian Tube Cancer recurrent uterine sarcoma uterine carcinosarcoma ovarian carcinosarcoma ovarian sarcoma recurrent endometrial cancer Endometrial Stromal Sarcoma	Procedure: chemotherapy  Drug: doxorubicin HCl liposome  Drug: paclitaxel	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--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

--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

New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Franco M. Muggia,  Study Chair,  Kaplan Cancer Center   

Study ID Numbers:  CDR0000066300; NYU-9708; NCI-G98-1427; NYGOG-NY9708
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003334
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08