A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed uterine carcinosarcoma

- Malignant mixed Müllerian tumor, homologous or heterologous type

- Recurrent or persistent disease

- Progressive disease after prior local therapy

- Measurable disease, defined as ≥ 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 not considered target lesions
except documented progression or biopsy to confirm persistence at least 90 days
after completion of radiation therapy

- Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma

- Initial treatment may have included high-dose therapy, consolidation, or
extended therapy administered after surgical or non-surgical assessment

- Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol
for the same patient population)

PATIENT CHARACTERISTICS:

Age

- Any age

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 normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Pulmonary

- No severe pulmonary disease requiring oxygen supplementation

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

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

- No neuropathy (sensory or motor) > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy

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

Chemotherapy

- See Disease Characteristics

- See Biologic therapy

- Recovered from prior chemotherapy

- No more than 1 prior cytotoxic chemotherapy regimen, either as a single agent or
combination therapy

- No prior docetaxel or gemcitabine

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

- At least 3 weeks since other prior therapy for the malignancy

- No prior cancer treatment that would preclude study therapy