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Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer Clinical research trials and Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer. Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer  Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
For Condition: recurrent endometrial cancer
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardGrendys, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, 1450
Australia
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75390-9032
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01605-2982
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-2233
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Additional Information:
Study ID Numbers: CDR0000068874; GOG-0129M
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023894
Other Recurrent Endometrial Cancer Studies:
1. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
2. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
3. Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
4. Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
5. Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Related Studies:
Other recurrent endometrial cancer Clinical Trials
Other Mississippi Clinical Trials
Other Jackson Clinical Trials
Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
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