A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial carcinoma

- Recurrent or persistent disease

- Refractory to curative or standard therapy

- 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 not considered target
lesions

- Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose,
consolidation, or extended therapy administered after surgical or non-surgical
assessment

- One additional non-cytotoxic regimen for recurrent or persistent disease
allowed, including monoclonal antibodies, cytokines, and small-molecule
inhibitors of signal transduction

- Ineligible for a higher priority GOG protocol

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

- SGOT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 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 and motor) ≥ grade 2

- No active infection requiring antibiotics

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- At least 3 weeks since prior biologic or immunologic therapy for malignant tumor

- No concurrent prophylactic growth factors

- No concurrent prophylactic thrombopoietic agents

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

- No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic
drugs)

Endocrine therapy

- At least 1 week since prior hormonal therapy for malignant tumor

- 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 malignant tumor

- No prior anticancer therapy that would preclude current protocol therapy

- No concurrent amifostine or other protective reagents