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

Inclusion Criteria

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