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Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023894
First received: September 13, 2001
Last updated: June 20, 2013
Last verified: May 2004
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: alvocidib
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2001
Study Completion Date: February 2006
Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023894

  Show 54 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Edward C. Grendys, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00023894     History of Changes
Other Study ID Numbers: CDR0000068874, GOG-0129M
Study First Received: September 13, 2001
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma

ClinicalTrials.gov processed this record on November 24, 2014