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Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer Clinical research trials and Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer. Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
For Condition: recurrent endometrial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
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 irofulven in treating patients who have persistent or recurrent refractory endometrial cancer.
Details: OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with persistent or recurrent, refractory endometrial carcinoma. II. Determine the nature and degree of toxicity of this treatment in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-4. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed endometrial carcinoma refractory to curative therapy or established treatments; Clinically or histologically confirmed persistent or recurrent disease - Bidimensionally measurable disease (ascites or pleural effusions not considered measurable) - Not eligible for higher priority GOG protocol --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 3 weeks since prior chemotherapy and recovered; No more than 1 prior chemotherapy regimen allowed (either single or combination cytotoxic drug therapy); No prior 6-hydroxymethylacylfulvene; No prior chemotherapy for other malignancy - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No prior radiotherapy for other malignancy - Surgery: At least 3 weeks since prior surgery and recovered --Patient Characteristics-- - Age: 18 and over - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count at least 100,000/mm3; Absolute neutrophil count at least 1,500/mm3 - Hepatic: Bilirubin normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No clinically uncontrolled dysrhythmia or signs of ischemia per ECG; No congestive heart failure requiring medication; No uncontrolled hypertension - Other: No significant active infection; No other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RussellSchilder, Study Chair, Gynecologic Oncology Group
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000067554; GOG-129L
Study Start Date: May 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005031
Other Recurrent Endometrial Cancer Studies:
1. Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
2. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
3. Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
4. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
5. Liposomal Doxorubicin in Treating Patients with Advanced or Recurrent Endometrial Cancer
Related Studies:
Other recurrent endometrial cancer Clinical Trials
Other Oklahoma Clinical Trials
Other Oklahoma City Clinical Trials
Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
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