Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
NCT ID: NCT00023894
Last Updated: 2013-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-07-31
2006-02-28
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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alvocidib
Eligibility Criteria
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Inclusion Criteria
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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Edward C. Grendys, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Tuft-New England Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
CCOP - M.D. Anderson Research Base
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, Australia
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Norwegian Radium Hospital
Oslo, , Norway
University of Birmingham
Birmingham, England, United Kingdom
Countries
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References
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Grendys EC Jr, Blessing JA, Burger R, Hoffman J. A phase II evaluation of flavopiridol as second-line chemotherapy of endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Aug;98(2):249-53. doi: 10.1016/j.ygyno.2005.05.017.
Other Identifiers
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GOG-0129M
Identifier Type: -
Identifier Source: secondary_id
CDR0000068874
Identifier Type: -
Identifier Source: org_study_id
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