Chemotherapy in Treating Patients With Sarcoma of the Uterus

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus.

Detailed Description
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OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of this drug in this patient population. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5 years.

Official Title
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Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

Conditions
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Endometrial Cancer, Sarcoma

Intervention / Treatment
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* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent or recurrent uterine sarcoma with documented disease progression after appropriate local therapy Leiomyosarcoma Malignant mixed mullerian tumor (mixed mesodermal tumor, mixed heterologous mesenchymal sarcoma) Mixed malignant Muellerian tumor (carcinosarcoma, homologous mesenchymal sarcoma) Endometrial stromal sarcoma Other uterine sarcomas Considered incurable Bidimensionally measurable disease consisting of abdominal, pelvic, chest, or other masses by palpation, x-ray, computed tomography, or ultrasound PATIENT CHARACTERISTICS: Age: Over 21 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF normal by MUGA scan Other: No clinically significant infection No other malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior therapy with cytotoxic drugs No prior doxorubicin HCl liposome No prior doxorubicin greater than 360 mg/m2 No other concurrent antineoplastic agents Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy No prior radiotherapy for any other malignancy Surgery: Recovered from prior surgery Other: No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pegylated liposomal doxorubicin hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma