Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: alvocidib

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00023894

CDR0000068874

GOG-0129M

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma.
• Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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