Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer
- Conditions
- Cervical CancerVaginal Cancer
- Registration Number
- NCT00002562
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
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 advanced, refractory, or recurrent cervical or vaginal cancer.
- Detailed Description
OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. II. Determine the frequency and severity of observed adverse effects on this study.
OUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.
PROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Ireland 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
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Women's Cancer Center
🇺🇸Palo Alto, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States