A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary endometrial carcinoma

- Recurrent or persistent disease

- Refractory to curative therapy or established treatment

- Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single
agent or combination therapy) for endometrial carcinoma

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

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- At least 1 target lesion outside previously irradiated field

- Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol, defined as
any active GOG phase III protocol for the same patient population

PATIENT CHARACTERISTICS:

Age:

- Any age

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 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- PT/PTT normal

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No prior thromboembolic events or thrombophlebitis

- No prior recent myocardial infarction

- No prior angina

- No prior cerebrovascular accident

- No prior transient ischemic attacks

Other:

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

- No grade 2 or greater sensory or motor neuropathy

- No active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered

Endocrine therapy:

- At least 1 week since prior hormonal therapy for endometrial carcinoma

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered

Surgery:

- At least 3 weeks since prior surgery for endometrial carcinoma and recovered

- At least 6 months since prior re-vascularization procedures (e.g., coronary artery
bypass graft, carotid endarterectomy or bypass, or angioplasty with or without
stents)

Other:

- At least 3 weeks since other prior therapy for endometrial carcinoma

- At least 6 months since prior thrombolytic procedures

- No prior cyclin-dependent kinase inhibitors

- No prior anticancer therapy that would preclude study

- No concurrent amifostine or other protective reagents