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Trial #NCT00262990
Ovarian Cancer Clinical Trials

Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer


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
Study ID: CEPO906A2303; Source: Novartis
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country Multiple Countries
Study type Interventional
Enrollment 829
Start date November 2005
Completion date
Phase Phase 3
Sponsor Novartis
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.
Eligibility:
Gender: Female
Age: 18 Years - N/A
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.
Outcome:
Primary outcome
  • To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
    Time frame: every 8 weeks
Secondary outcome
  • To determine overall best tumor response (CR, PR, SD, PD and Unknown)
    Time frame: end of study
  • To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)
    Time frame: End of study
  • To determine the progression-free survival (PFS) of patients treated with patupilone
    Time frame: end of study
  • To determine the time to disease progression (TTP) of patients treated with patupilone
    Time frame: end of study
  • To evaluate the pharmacokinetics (PK) of patupilone from all patients
    Time frame: end of study
  • To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events
    Time frame: end of study
  • To investigate the safety and tolerability of patupilone
    Time frame: end of study
Contacts:
  • Novartis Pharmaceuticals; Novartis Pharmaceuticals (Study Director)
Location Country Status
Alaska Cancer Research & Education Center Anchorage, Alaska United States
Northern Arizona Hematology & Oncology Associates Flagstaff, Arizona United States
Mayo Center for Women's Health Scottsdale, Arizona United States
Northern Arizona Hematology & Oncology Associates Sedona, Arizona United States
Genesis Cancer Center Hot Springs, Arkansas United States
University of Arkansas for Medical Sciences Little Rock, Arkansas United States
Yanagihara, Ronald H. Gilroy, California United States
California Cancer Care, Inc. Greenbrae, California United States
University of California - San Diego/ Moores Cancer Center La Jolla, California United States
LAC & USC Women's & Children's Hospital Los Angeles, California United States
Gynecologic Oncology associates Newport Beach, California United States
UC Davis Cancer Center Sacramento, California United States
California Pacific Medical Center Research Institute San Francisco, 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
Yale University School of Medicine New Haven, Connecticut United States
Christiana Gynecologic Oncology, LLC Newark, Delaware United States
Washington Hospital Center/Medstar Research Institute Washington, District of Columbia United States
Florida Gynecologic Oncology Fort Myers, Florida United States
Miami Cancer Center at Mercy Hospital Miami, Florida United States
Advanced Medical Specialties Miami, Florida United States
University of Miami Miami, Florida United States
Mt. Sinai Medical Center Miami, Florida United States
Miami Cancer Center at University Hospital Miami, Florida United States
Ocala Oncology Center Ocala, Florida United States
MD Anderson Cancer Center of Orlando Orlando, Florida United States
Oncology & Hematology Associates of West Broward Tamarac, Florida United States
Xelero Medical Research/Giselle Ghurani Tampa, Florida United States
Medical College of Georgia Augusta, Georgia United States
Memorial Health University Medical Center Savannah, Georgia United States
Kapiolani Medical Center for Women and Children/Univ. of HI Honolulu, Hawaii United States
Rush University Medical Center Chicago, Illinois United States
Northwest Memorial Hospital Chicago, Illinois United States
Cancer Institute of Central Illinois/Decatur Memorial Hospital Decatur, Illinois United States
Indiana University Obstetrics Indianapolis, Indiana United States
Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation Indianapolis, Indiana United States
Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center Indianapolis, Indiana United States
Northern Indiana Cancer Research Consortium South Bend, Indiana United States
Louisville Oncology Louisville, Kentucky United States
Franklin Square Hospital Center Baltimore, Maryland United States
Boston University Medical Center Hospital Boston, Massachusetts United States
Providence Cancer Center Southfield, Michigan United States
Minnesota Oncology/Hematology, PA Burnsville, Minnesota United States
St. Luke's Hospital Duluth, Minnesota United States
Minnesota Oncology/Hematology, PA Edina, Minnesota United States
Minnesota Oncology/Hematology Associates of Central Illinois Minneapolis, Minnesota United States
University of Minnesota Minneapolis, Minnesota United States
Metro-MN CCOP St. Louis Park, Minnesota United States
Minnesota Oncology Hematology St. Paul, Minnesota United States
The West Clinic Corinth, Mississippi United States
The West Clinic Southaven, Mississippi United States
St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute Kansas City, Missouri United States
Washington University School of Medicine St. Louis, Missouri United States
Southeast Nebraska Oncology/Southeast Nebraska Cancer Center Lincoln, Nebraska United States
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada United States
Women's Cancer Center of Nevada Las Vegas, Nevada United States
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire United States
Hematology and Oncology Associates of Northern New Jersey Morristown, New Jersey United States
University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey New Brunswick, New Jersey United States
New York Oncology Hematology, P.C. Albany, New York United States
Schwartz Gynecologic Oncology, PLLC Babylon, New York United States
Bellview Hospital New York, New York United States
NYU Cancer Institute New York, New York United States
New York University School of Medicine/NYU Cancer Institute New York, New York United States
St. Vincent Catholic Medical Center of New York Staten Island, New York United States
Brody School of Medicine Greenville, North Carolina United States
New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington, North Carolina United States
Ohio State University Medical Center Columbus, Ohio United States
Camelot Women's Cancer Columbus, Ohio United States
The Arthur G. James Cancer Hospital Columbus, Ohio United States
Cancer Care Associates Tulsa, Oklahoma United States
Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center Eugene, Oregon United States
Northwest Cancer Specialists, P.C. Portland, Oregon United States
Willamette Valley Cancer Center Springfield, Oregon United States
Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania United States
Magee - Women's Hospital Pittsburgh, Pennsylvania United States
GYN Oncology Research/Gynecologic Oncology Research & Development, LLC Greenville, South Carolina United States
Chattanooga GYN Oncology Chattanooga, Tennessee United States
Hall and Martin MDs, PC Knoxville, Tennessee United States
West Clinic Memphis, Tennessee United States
The West Clinic Memphis, Tennessee United States
Texas Oncology Austin, Texas United States
Texas Oncology, P.A. Austin, Texas United States
Texas Oncology, P.A. Bedford, Texas United States
Sammons Cancer Center Dallas, Texas United States
Texas Oncology, P.A. Dallas, Texas United States
Texas Oncology, P.A. Dallas, Texas United States
Texas Oncology, P.A. Fort Worth, Texas United States
Oncology Consultants P.A. Houston, Texas United States
Cancer Care Center of South Texas San Antonio, Texas United States
Waco Cancer Care & Research Center Waco, Texas United States
Utah Cancer Specialists Salt Lake City, Utah United States
Fletcher Allen Health Care Burlington, Vermont United States
Cancer Outreach Associates Abingdon, Virginia United States
Northern Virginia Pelvic Surgery Associates Annandale, Virginia United States
Virginia Oncology Associates Newport News, Virginia United States
Virginia Oncology Associates Norfolk, Virginia United States
Virginia Commonwealth University/VCU Massey Cancer Center Richmond, Virginia United States
Gersh, Robert Spokane, Washington United States
Northwest Cancer Specialists Vancouver, Washington United States
Northwest Cancer Specialists, P.C. Vancouver, Washington United States
Yakima Valley Memorial Hospital Yakima, Washington United States
Aurora Medical Gyn Group West Allis, Wisconsin United States
Novartis Investigative Site Adelaide, Australia
Novartis Investigative Site Herston, Australia
Novartis Investigative Site Nedlands, WA, Australia
Novartis Investigative Site South Brisbane, Australia
Novartis Investigative Site St. Leonards, Australia
Novartis Investigative Site Wodonga, Australia
BC Cancer Agency Vancouver, British Columbia Canada
Novartis Investigative Site Calgary, Canada
Novartis Investigative Site Montreal, Canada
Novartis Investigative Site North York, Canada
Novartis Investigative Site Quebec, Canada
Novartis Investigative Site Sherbrooke, Canada
Novartis Investigative Site Toronto, Canada
Novartis Investigative Site Odense, Denmark
Novartis Investigative Site Vejle, Denmark
Novartis Investigative Site Helsinki, Finland
Novartis Investigative Site Kuopio, Finland
Novartis Investigative Site Tampere, Finland
Novartis Investigative Site Amboise, France
Novartis Investigative Site Bordeaux, France
Novartis Investigative Site Caen Cedex, France
Novartis Investigative Site Herblain Cedec, France
Novartis Investigative Site Villejuif Cedex, France
Novartis Investigative Site Athens, Greece
Novartis Investigative Site Bologna, Italy
Novartis Investigative Site Milano, Italy
Novartis Investigative Site Modena, Italy
Novartis Investigative Site Monza, Italy
Novartis Investigative Site Padova, Italy
Novartis Investigative Site Roma, Italy
Novartis Investigative Site Torino, Italy
Novartis Investigative Site Krakow, Poland
Novartis Investigative Site Cape Town, South Africa
Novartis Investigative Site Johannesburg, Gauteng, South Africa
Novartis Investigative Site Klerksdorp, South Africa
Novartis Investigative Site Port Elizabeth, South Africa
Novartis Investigative Site Pretoria, Gauteng, South Africa
Novartis Investigative Site Pretoria, Guateng, South Africa
Novartis Investigative Site Sandton, Gauteng, South Africa
Novartis Investigative Site Barcelona, Spain
Novartis Investigative Site Madrid, Spain
Novartis Investigative Site Glasgow, United Kingdom
Novartis Investigative Site London, United Kingdom
Novartis Investigative Site Wirral, United Kingdom
Novartis Investigative Site Wolverhampton, United Kingdom
Sponsors:
  • Novartis Pharmaceuticals - (Lead Sponsor)

Related trials: Terms
  • recurrent cancer
  • platinum chemotherapy
  • primary cancer
  • peritoneal cancer
  • Epithelial ovarian cancer
  • doxorubicin
  • taxane platinum resistant
  • fallopian tube cancer
  • taxane chemotherapy
  • Patupilone
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