Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alvocidib

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