Spots Global Cancer Trial Database for S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
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Trial Identification
Brief Title: S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
Official Title: Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy
Study ID: NCT00003120
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter period of time is as effective as a standard course of treatment for advanced ovarian cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
Detailed Description: OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on progression free survival and overall survival in women with advanced ovarian, fallopian tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated with prolonged paclitaxel administration in these patients. OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression or 1 year from registration, then every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 5 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
MBCCOP - Gulf Coast, Mobile, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
Scripps Clinic Cancer Center, La Jolla, California, United States
Veterans Affairs Medical Center - Long Beach, Long Beach, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California Davis Medical Center, Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Boston Medical Center, Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
Providence Hospital - Southfield, Southfield, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
Oregon Cancer Center, Portland, Oregon, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
CCOP - Columbia River Program, Portland, Oregon, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - Dallas, Dallas, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Texas Tech University Health Science Center, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Contact Details
Name: Maurie Markman, MD
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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