A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

Inclusion Criteria

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