A Phase II Evaluation Of Docetaxel And Gemcitabine Plus G-CSF In The Treatment Of Recurrent Or Persistent Leiomyosarcoma Of The Uterus

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed uterine leiomyosarcoma

- Recurrent or persistent disease that is refractory to curative therapy or
established treatments

- Must have received 1 prior chemotherapy regimen that may include high-dose
therapy, consolidation, or extended therapy after surgical or nonsurgical
assessment

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- Lesions within a previously irradiated field allowed provided progression is
documented or biopsy is obtained to confirm persistence at least 90 days
following completion of radiation therapy

- Ineligible for a high priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- GOG 0-2

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 1.1 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- No active infection requiring antibiotics

- No motor or sensory neuropathy greater than grade 1

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal
antibodies, cytokines, or small-molecule signal transduction inhibitors) for
recurrent or persistent disease

- At least 3 weeks since prior biologic or immunologic therapy for this disease

Chemotherapy:

- See Disease Characteristics

- See Biologic therapy

- At least 3 weeks since prior chemotherapy and recovered

- No prior docetaxel or gemcitabine

- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including
retreatment with initial regimens

- No prior chemotherapy for another malignancy that would preclude study

Endocrine therapy:

- At least 1 week since prior hormonal therapy for this disease

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- Recovered from prior recent surgery

Other:

- At least 3 weeks since other prior therapy for this disease

- No concurrent amifostine or other protective agents