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Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
This study has been completed.
First Received: September 13, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023894
  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 II

Study Type: Interventional
Study Design: 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023894

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3864
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Tuft-New England Medical Center
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01605-2982
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103-1489
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
North Shore University Hospital
Manhasset, New York, United States, 11030
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11794-8091
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0526
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-2233
United States, Tennessee
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
CCOP - M.D. Anderson Research Base
Houston, Texas, United States, 77030-4009
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75390-9032
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Australia, New South Wales
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, Australia, 1450
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
United Kingdom, England
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Edward C. Grendys, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068874, GOG-0129M
Study First Received: September 13, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00023894     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Genital Diseases, Female
Flavopiridol
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Uterine Neoplasms
Growth Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009