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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus



Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

For Condition: uterine leiomyosarcoma,recurrent uterine sarcoma
Status: Completed
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 paclitaxel in treating patients with recurrent or persistent cancer of the uterus.
Details: OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher priority. II. Determine the nature and degree of toxic effects of paclitaxel in this group of patients. PROTOCOL OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours. Patients in complete remission, partial remission, or stable disease undergo at least 3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects prohibit further treatment. All patients are followed until death. PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients over 2.5 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or established treatments Measurable disease required Must have failed local therapeutic measures and must be considered incurable Not eligible for GOG protocols of higher priority --Prior/Concurrent Therapy-- At least 3 weeks since prior therapy to malignant tumor Biologic therapy: Not specified Chemotherapy: - Recovery from prior chemotherapy required - No more than 1 prior chemotherapy regimen allowed - No prior paclitaxel - No prior chemotherapy for any malignancy from which the patient is disease-free for at least 5 years Endocrine therapy: Not specified Radiotherapy: - Recovery from prior radiation therapy required - No prior radiation therapy for any malignancy from which the patient is disease-free for at least 5 years Surgery: Recovery from prior surgery required --Patient Characteristics-- Age: Not specified Performance status: GOG 0-3 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 and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: - No unstable angina within 6 months OR - No myocardial infarction within 6 months - Abnormal cardiac condition (e.g., bundle branch block, heart block) allowed if stable for 6 months Other: - No significant infection - No concomitant malignancy other than nonmelanomatous skin cancer
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DonaldGallup,  Study Chair,  Gynecologic Oncology Group

State University of New York Health Sciences Center - Stony Brook
Stony Brook,  New York,  11790-9832
United States
 

CCOP - Baptist Cancer Institute
Memphis,  Tennessee,  38117
United States
 

Radiation Oncology Branch
Bethesda,  Maryland,  20892
United States
 

Rush-Presbyterian-St. Luke's Medical Center
Chicago,  Illinois,  60612
United States
 

University of Washington Medical Center
Seattle,  Washington,  98195-6043
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637
United States
 

University of Massachusetts Memorial Medical Center
Worcester,  Massachusetts,  01655
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia,  Pennsylvania,  19107
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem,  North Carolina,  27157-1082
United States
 

CCOP - Columbia River Program
Portland,  Oregon,  97213
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80262
United States
 

Washington University School of Medicine
St. Louis,  Missouri,  63110
United States
 

USC/Norris Comprehensive Cancer Center
Los Angeles,  California,  90033-0800
United States
 

Abington Memorial Hospital
Abington,  Pennsylvania,  19001
United States
 

University of Iowa Hospitals and Clinics
Iowa City,  Iowa,  52242
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

University of Rochester Cancer Center
Rochester,  New York,  14642
United States
 

Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C.,  District of Columbia,  20007
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

Medical College of Georgia Comprehensive Cancer Center
Augusta,  Georgia,  30912-4000
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5265
United States
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

Brookview Research, Inc.
Winston Salem,  North Carolina,  27103
United States
 

Women's Cancer Center
Palo Alto,  California,  94304
United States
 

CCOP - Greater Phoenix
Phoenix,  Arizona,  85006-2726
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

Cleveland Clinic Cancer Center
Cleveland,  Ohio,  44195
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68131
United States
 

Medicine Branch
Bethesda,  Maryland,  20892
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104
United States
 

Cancer Center of Albany Medical Center
Albany,  New York,  12208
United States
 

CCOP - Central Illinois
Springfield,  Illinois,  62526
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

State University of New York Health Science Center at Brooklyn
Brooklyn,  New York,  11203
United States
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

Johns Hopkins Oncology Center
Baltimore,  Maryland,  21287
United States
 

Cooper Hospital/University Medical Center
Camden,  New Jersey,  08103
United States
 

Barrett Cancer Center, The University Hospital
Cincinnati,  Ohio,  45219
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
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Pennsylvania Hospital
Philadelphia,  Pennsylvania,  19107
United States
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030
United States
 

MBCCOP - Hawaii
Honolulu,  Hawaii,  96813
United States
 

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa,  Oklahoma,  74136
United States
 

Milton S. Hershey Medical Center
Hershey,  Pennsylvania,  17033
United States
 

University of Alabama Comprehensive Cancer Center
Birmingham,  Alabama,  35294
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

NCIC-Clinical Trials Group
Kingston,  Ontario,  K7L 3N6
Canada
 

University of Oklahoma College of Medicine
Oklahoma City,  Oklahoma,  73190
United States
 

Tacoma General Hospital
Tacoma,  Washington,  98405
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

Cancer Center, University of Virginia HSC
Charlottesville,  Virginia,  22908
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065702;  GOG-131C
Study Start Date: August 1997
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003054

Other Recurrent Uterine Sarcoma Studies:
1. Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus

2. Chemotherapy in Treating Patients With Sarcoma of the Uterus

3. Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

4. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus

5. Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus

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Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

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