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Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus Clinical research trials and Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus. Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus clinical trial. Human subjects often receive the most effective healthcare possible for their Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus  Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus
Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus
For Condition: uterine leiomyosarcoma,recurrent uterine sarcoma
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 gemcitabine in treating patients with recurrent or refractory cancer of the uterus.
Details: OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients. PROTOCOL OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments; Failed local therapeutic measures and considered incurable - Measurable disease - Not eligible for a higher priority GOG protocol --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior biologic therapy - Chemotherapy: At least 3 weeks since prior chemotherapy and recovered; No prior gemcitabine; No more than 1 prior chemotherapy regimen (single agent or combination therapy) - Endocrine therapy: At least 3 weeks since prior endocrine therapy - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered - 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: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal; SGOT no greater than 3 times normal; Alkaline phosphatase no greater than 3 times normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: No significant infection; At least 5 years since any other invasive malignancy except nonmelanoma skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KatherineLook, Study Chair, Gynecologic Oncology Group
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
NCIC-Clinical Trials Group
Kingston, Ontario, K7L 3N6
Canada
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Additional Information:
Study ID Numbers: CDR0000066265; GOG-131E
Study Start Date: September 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003316
Other Uterine Leiomyosarcoma Studies:
1. Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
2. Chemotherapy in Treating Patients With Sarcoma of the Uterus
3. Combination Chemotherapy and Filgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
4. Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus
5. Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Carcinosarcoma
Related Studies:
Other uterine leiomyosarcoma Clinical Trials
Other Washington Clinical Trials
Other Tacoma Clinical Trials
Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus
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