A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
Trial Information
A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
Outcome Time Frame:
every 8 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CEPO906A2303
NCT ID:
NCT00262990
Start Date:
November 2005
Completion Date:
Related Keywords:
- Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Neoplasms
- Epithelial ovarian cancer
- fallopian tube cancer
- peritoneal cancer
- primary cancer
- recurrent cancer
- doxorubicin
- taxane chemotherapy
- platinum chemotherapy
- Patupilone
- taxane platinum resistant
- Neoplasms
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Fletcher Allen Health Care | Burlington, Vermont 05401 |
| Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| California Cancer Care, Inc. | Greenbrae, California 94904-2007 |
| Virginia Oncology Associates | Newport News, Virginia 23606 |
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Ocala Oncology Center | Ocala, Florida 34474 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| St. Luke's Hospital | Duluth, Minnesota 55805-2193 |
| Medical College of Georgia | Augusta, Georgia 30912 |
| Gynecologic Oncology Associates | Newport Beach, California 92663 |
| Genesis Cancer Center | Hot Springs, Arkansas 71913 |
| NYU Cancer Institute | New York, New York 10016 |
| Oncology & Hematology Associates of West Broward | Tamarac, Florida 33321 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
| Northwest Cancer Specialists | Vancouver, Washington 98664 |
| University of Colorado Health Sciences Center | Denver, Colorado 80262 |
| West Clinic | Memphis, Tennessee 38117 |
| New York Oncology Hematology, P.C. | Albany, New York 12208 |
| Ohio State University Medical Center | Columbus, Ohio 43210 |
| California Pacific Medical Center Research Institute | San Francisco, California 94115 |
| Texas Oncology | Dallas, Texas |
| UC Davis Cancer Center | Sacramento, California 95817 |
| University of Miami | Miami, Florida 33136 |
| Florida Gynecologic Oncology | Fort Myers, Florida 33901 |
| Louisville Oncology | Louisville, Kentucky 40202 |
| Chattanooga GYN Oncology | Chattanooga, Tennessee 37403 |
| Utah Cancer Specialists | Salt Lake City, Utah 84106 |
| Medical Oncology Associates of Wyoming Valley, PC | Kingston, Pennsylvania 18704 |
| The West Clinic | Memphis, Tennessee 38120 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Providence Cancer Center | Southfield, Michigan 48075 |
| Memorial Health University Medical Center | Savannah, Georgia 31404 |
| Anschutz Cancer Pavilion | Aurora, Colorado |
| Northern Indiana Cancer Research Consortium | South Bend, Indiana |
| Northern Virginia Pelvic Surgery Associates | Annandale, Virginia 22003 |
| Northwest Cancer Specialists, P.C. | Vancouver, Washington |
| Sammons Cancer Center | Dallas, Texas |
| Northern Arizona Hematology & Oncology Associates | Sedona, Arizona 86336 |
| Waco Cancer Care & Research Center | Waco, Texas 76712 |
| Minnesota Oncology Hematology | Minneapolis, Minnesota 55404 |
| Oncology Consultants P.A. | Houston, Texas 77024 |
| Brody School of Medicine | Greenville, North Carolina 27858 |
| Miami Cancer Center at Mercy Hospital | Miami, Florida 33133 |
| Mt. Sinai Medical Center | Miami Beach, Florida 33140 |
| Cancer Outreach Associates | Abingdon, Virginia 24211 |
| Alaska Cancer Research & Education Center | Anchorage, Alaska 99508 |
| Mayo Center for Women's Health | Scottsdale, Arizona 85259 |
| Yanagihara, Ronald H. | Gilroy, California 95020 |
| University of California - San Diego/ Moores Cancer Center | La Jolla, California 92093-0987 |
| LAC & USC Women's & Children's Hospital | Los Angeles, California 90033 |
| Anschutz Cancer Pavilion - Clinical Investigations Core | Aurora, Colorado 90045 |
| Christiana Gynecologic Oncology, LLC | Newark, Delaware 19713 |
| Washington Hospital Center/Medstar Research Institute | Washington, District of Columbia 20010-2931 |
| Advanced Medical Specialties | Miami, Florida 33176 |
| Miami Cancer Center at University Hospital | Miami, Florida 33133 |
| MD Anderson Cancer Center of Orlando | Orlando, Florida 32806 |
| Xelero Medical Research/Giselle Ghurani | Tampa, Florida 33607 |
| Kapiolani Medical Center for Women and Children/Univ. of HI | Honolulu, Hawaii 96826 |
| Northwest Memorial Hospital | Chicago, Illinois 60611 |
| Cancer Institute of Central Illinois/Decatur Memorial Hospital | Decatur, Illinois 62526 |
| Indiana University Obstetrics | Indianapolis, Indiana 00144 |
| Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation | Indianapolis, Indiana 46267 |
| Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center | Indianapolis, Indiana 46202 |
| Boston University Medical Center Hospital | Boston, Massachusetts 02118 |
| Minnesota Oncology/Hematology, PA | Burnsville, Minnesota 55337 |
| Minnesota Oncology/Hematology Associates of Central Illinois | Minneapolis, Minnesota 55404 |
| Metro-MN CCOP | St. Louis Park, Minnesota 55416 |
| The West Clinic | Corinth, Mississippi 38834 |
| St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute | Kansas City, Missouri 64111 |
| Southeast Nebraska Oncology/Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
| Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
| Hematology and Oncology Associates of Northern New Jersey | Morristown, New Jersey 07962 |
| University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey | New Brunswick, New Jersey 07090 |
| Schwartz Gynecologic Oncology, PLLC | Babylon, New York 11702 |
| Bellview Hospital | New York, New York 10016 |
| New York University School of Medicine/NYU Cancer Institute | New York, New York 10016 |
| St. Vincent Catholic Medical Center of New York | Staten Island, New York 10310 |
| New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington, North Carolina 28401 |
| Camelot Women's Cancer | Columbus, Ohio 43214 |
| The Arthur G. James Cancer Hospital | Columbus, Ohio 43214 |
| Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center | Eugene, Oregon 97401-8122 |
| Northwest Cancer Specialists, P.C. | Portland, Oregon 97227 |
| Magee - Women's Hospital | Pittsburgh, Pennsylvania 15213 |
| GYN Oncology Research/Gynecologic Oncology Research & Development, LLC | Greenville, South Carolina 29601 |
| Hall and Martin MDs, PC | Knoxville, Tennessee 37920 |
| Cancer Care Center of South Texas | San Antonio, Texas 78229 |
| Virginia Commonwealth University/VCU Massey Cancer Center | Richmond, Virginia 23298 |
| Gersh, Robert | Spokane, Washington 99202 |
| Aurora Medical Gyn Group | West Allis, Wisconsin 53227 |
