Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma

OBJECTIVES:

• Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim (G-CSF) support, in terms of disease response, in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma.
• Determine the tolerability of this regimen in these patients.
• Correlate response with tumor expression of the apoptosis-regulating proteins bax, bcl-2, and survivin in these patients.

OUTLINE: Patients are stratified according to prior radiotherapy to the pelvis (yes vs no).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim (G-CSF) subcutaneously on days 9-15. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response may receive 2 additional courses of therapy.

Patients are followed every 3 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 38-82 patients (19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed leiomyosarcoma (LMS) or other soft tissue sarcoma

• No gastrointestinal stromal tumors, chondrosarcoma, Kaposi's sarcoma, Ewing's sarcoma, osteosarcoma, or mesotheliomas
• Recurrent or progressive disease defined as an increase in the size of any existing tumor (or the development of new tumors) that is not amenable to definitive surgical therapy
• No prior chemotherapy OR
• Failed no more than 2 prior chemotherapy regimens for LMS of the uterus or other soft tissue sarcoma
• Bidimensionally measurable disease by physical examination or medical imaging techniques

• Ascites and pleural effusions are not considered measurable disease
• No uncontrolled CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• No active or uncontrolled infection
• No other prior malignancy except non-metastatic squamous cell or basal cell skin cancer or non-invasive carcinoma in situ of the cervix
• No history of grade 3 or 4 peripheral neuropathy
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy
• No prior gemcitabine or docetaxel

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 6 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics