Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
- Conditions
- Peritoneal NeoplasmsOvarian CancerFallopian Tube Cancer
- Interventions
- Drug: EPO906 (Patupilone)
- Registration Number
- NCT00262990
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 829
- 18 years of age or older
- Confirmed diagnosis of ovarian, fallopian or peritoneal cancer
- No more than three chemotherapy regimens
- Most recent regimen must have been platinum based
- Have an unresolved bowel obstruction
- Have had previous chemotherapy within 3 weeks
- Recovering from any surgery for any cause
Other protocol-defined inclusion/exclusion criteria will apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patupilone EPO906 (Patupilone) - doxorubicin doxorubicin -
- Primary Outcome Measures
Name Time Method To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer every 8 weeks
- Secondary Outcome Measures
Name Time Method To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD) End of study To determine the progression-free survival (PFS) of patients treated with patupilone end of study To determine the time to disease progression (TTP) of patients treated with patupilone end of study To determine overall best tumor response (CR, PR, SD, PD and Unknown) end of study To investigate the safety and tolerability of patupilone end of study To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events end of study To evaluate the pharmacokinetics (PK) of patupilone from all patients end of study
Trial Locations
- Locations (96)
The Arthur G. James Cancer Hospital
🇺🇸Columbus, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Magee - Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Boston University Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
University of Miami
🇺🇸Miami, Florida, United States
Advanced Medical Specialties
🇺🇸Miami, Florida, United States
Indiana University Obstetrics
🇺🇸Indianapolis, Indiana, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Bellview Hospital
🇺🇸New York, New York, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Gynecologic Oncology associates
🇺🇸Newport Beach, California, United States
Alaska Cancer Research & Education Center
🇺🇸Anchorage, Alaska, United States
Yanagihara, Ronald H.
🇺🇸Gilroy, California, United States
University of California - San Diego/ Moores Cancer Center
🇺🇸La Jolla, California, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Mt. Sinai Medical Center
🇺🇸Miami, Florida, United States
NYU Cancer Institute
🇺🇸New York, New York, United States
Camelot Women's Cancer
🇺🇸Columbus, Ohio, United States
Miami Cancer Center at Mercy Hospital
🇺🇸Miami, Florida, United States
Miami Cancer Center at University Hospital
🇺🇸Miami, Florida, United States
Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation
🇺🇸Indianapolis, Indiana, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Oncology & Hematology Associates of West Broward
🇺🇸Tamarac, Florida, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
Medical Oncology Associates of Wyoming Valley, PC
🇺🇸Kingston, Pennsylvania, United States
Northwest Cancer Specialists, P.C.
🇺🇸Vancouver, Washington, United States
GYN Oncology Research/Gynecologic Oncology Research & Development, LLC
🇺🇸Greenville, South Carolina, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Minnesota Oncology/Hematology Associates of Central Illinois
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Cancer Care Center of South Texas
🇺🇸San Antonio, Texas, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Minnesota Oncology Hematology
🇺🇸Saint Paul, Minnesota, United States
Northern Arizona Hematology & Oncology Associates
🇺🇸Sedona, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
California Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
St. Vincent Catholic Medical Center of New York
🇺🇸Staten Island, New York, United States
New York University School of Medicine/NYU Cancer Institute
🇺🇸New York, New York, United States
Chattanooga GYN Oncology
🇺🇸Chattanooga, Tennessee, United States
Northern Virginia Pelvic Surgery Associates
🇺🇸Annandale, Virginia, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Novartis Investigative Site
🇬🇧Wolverhampton, United Kingdom
Mayo Center for Women's Health
🇺🇸Scottsdale, Arizona, United States
Washington Hospital Center/Medstar Research Institute
🇺🇸Washington, District of Columbia, United States
Hematology and Oncology Associates of Northern New Jersey
🇺🇸Morristown, New Jersey, United States
Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
LAC & USC Women's & Children's Hospital
🇺🇸Los Angeles, California, United States
Florida Gynecologic Oncology
🇺🇸Fort Myers, Florida, United States
St. Luke's Hospital
🇺🇸Duluth, Minnesota, United States
Metro-MN CCOP
🇺🇸Saint Louis Park, Minnesota, United States
Christiana Gynecologic Oncology, LLC
🇺🇸Newark, Delaware, United States
Northwest Memorial Hospital
🇺🇸Chicago, Illinois, United States
Minnesota Oncology/Hematology, PA
🇺🇸Edina, Minnesota, United States
Cancer Institute of Central Illinois/Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Southeast Nebraska Oncology/Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Schwartz Gynecologic Oncology, PLLC
🇺🇸Babylon, New York, United States
University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey
🇺🇸New Brunswick, New Jersey, United States
Providence Cancer Center
🇺🇸Southfield, Michigan, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
🇺🇸Wilmington, North Carolina, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Cancer Outreach Associates
🇺🇸Abingdon, Virginia, United States
West Clinic
🇺🇸Memphis, Tennessee, United States
Aurora Medical Gyn Group
🇺🇸West Allis, Wisconsin, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
Texas Oncology, P.A.
🇺🇸Fort Worth, Texas, United States
Willamette Valley Cancer Center
🇺🇸Springfield, Oregon, United States
Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Waco Cancer Care & Research Center
🇺🇸Waco, Texas, United States
Hall and Martin MDs, PC
🇺🇸Knoxville, Tennessee, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Gersh, Robert
🇺🇸Spokane, Washington, United States
Oncology Consultants P.A.
🇺🇸Houston, Texas, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
UC Davis Cancer Center
🇺🇸Sacramento, California, United States
Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Anschutz Cancer Pavilion - Clinical Investigations Core
🇺🇸Aurora, Colorado, United States
University Of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Xelero Medical Research/Giselle Ghurani
🇺🇸Tampa, Florida, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
MD Anderson Cancer Center of Orlando
🇺🇸Orlando, Florida, United States
Kapiolani Medical Center for Women and Children/Univ. of HI
🇺🇸Honolulu, Hawaii, United States
Virginia Commonwealth University/VCU Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Louisville Oncology
🇺🇸Louisville, Kentucky, United States
St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute
🇺🇸Kansas City, Missouri, United States
Texas Oncology
🇺🇸Austin, Texas, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States