Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma

OBJECTIVES:

• Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
• Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed uterine leiomyosarcoma

• Advanced, persistent, or recurrent disease
• Documented disease progression
• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• At least 1 target lesion

• Tumors within a previously irradiated field are considered nontarget lesions
• Ineligible for higher priority GOG protocols (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

• Adult

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No neuropathy (sensory or motor) > grade 1
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No active infection requiring antibiotics
• No known hypersensitivity to E. coli-derived proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy for the malignancy

Endocrine therapy

• At least 1 week since prior hormonal therapy for the malignancy
• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics
• Recovered from prior radiotherapy

Surgery

• Recovered from prior surgery

Other

• Recovered from all other prior therapy
• No prior cancer treatment that would preclude study treatment
• No concurrent amifostine or other protective agents