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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
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Thank you

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 MedicineSaint Louis, Missouri  63110
Fletcher Allen Health CareBurlington, Vermont  05401
Yakima Valley Memorial HospitalYakima, Washington  98902
Rush University Medical CenterChicago, Illinois  60612-3824
Texas Oncology, P.A.Dallas, Texas  75246
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Franklin Square Hospital CenterBaltimore, Maryland  21237
California Cancer Care, Inc.Greenbrae, California  94904-2007
Virginia Oncology AssociatesNewport News, Virginia  23606
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
University of MinnesotaMinneapolis, Minnesota  55455
St. Luke's HospitalDuluth, Minnesota  55805-2193
Medical College of GeorgiaAugusta, Georgia  30912
Gynecologic Oncology AssociatesNewport Beach, California  92663
Genesis Cancer CenterHot Springs, Arkansas  71913
NYU Cancer InstituteNew York, New York  10016
Oncology & Hematology Associates of West BrowardTamarac, Florida  33321
Cancer Care AssociatesTulsa, Oklahoma  74136
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
Northwest Cancer SpecialistsVancouver, Washington  98664
University of Colorado Health Sciences CenterDenver, Colorado  80262
West ClinicMemphis, Tennessee  38117
New York Oncology Hematology, P.C.Albany, New York  12208
Ohio State University Medical CenterColumbus, Ohio  43210
California Pacific Medical Center Research InstituteSan Francisco, California  94115
Texas OncologyDallas, Texas  
UC Davis Cancer CenterSacramento, California  95817
University of MiamiMiami, Florida  33136
Florida Gynecologic OncologyFort Myers, Florida  33901
Louisville OncologyLouisville, Kentucky  40202
Chattanooga GYN OncologyChattanooga, Tennessee  37403
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
The West ClinicMemphis, Tennessee  38120
Yale University School Of MedicineNew Haven, Connecticut  06520
Providence Cancer CenterSouthfield, Michigan  48075
Memorial Health University Medical CenterSavannah, Georgia  31404
Anschutz Cancer PavilionAurora, Colorado  
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Northern Virginia Pelvic Surgery AssociatesAnnandale, Virginia  22003
Northwest Cancer Specialists, P.C.Vancouver, Washington  
Sammons Cancer CenterDallas, Texas  
Northern Arizona Hematology & Oncology AssociatesSedona, Arizona  86336
Waco Cancer Care & Research CenterWaco, Texas  76712
Minnesota Oncology HematologyMinneapolis, Minnesota  55404
Oncology Consultants P.A.Houston, Texas  77024
Brody School of MedicineGreenville, North Carolina  27858
Miami Cancer Center at Mercy HospitalMiami, Florida  33133
Mt. Sinai Medical CenterMiami Beach, Florida  33140
Cancer Outreach AssociatesAbingdon, Virginia  24211
Alaska Cancer Research & Education CenterAnchorage, Alaska  99508
Mayo Center for Women's HealthScottsdale, Arizona  85259
Yanagihara, Ronald H.Gilroy, California  95020
University of California - San Diego/ Moores Cancer CenterLa Jolla, California  92093-0987
LAC & USC Women's & Children's HospitalLos Angeles, California  90033
Anschutz Cancer Pavilion - Clinical Investigations CoreAurora, Colorado  90045
Christiana Gynecologic Oncology, LLCNewark, Delaware  19713
Washington Hospital Center/Medstar Research InstituteWashington, District of Columbia  20010-2931
Advanced Medical SpecialtiesMiami, Florida  33176
Miami Cancer Center at University HospitalMiami, Florida  33133
MD Anderson Cancer Center of OrlandoOrlando, Florida  32806
Xelero Medical Research/Giselle GhuraniTampa, Florida  33607
Kapiolani Medical Center for Women and Children/Univ. of HIHonolulu, Hawaii  96826
Northwest Memorial HospitalChicago, Illinois  60611
Cancer Institute of Central Illinois/Decatur Memorial HospitalDecatur, Illinois  62526
Indiana University ObstetricsIndianapolis, Indiana  00144
Gynecologic Oncology of Indiana/St. Francis Cancer Research FoundationIndianapolis, Indiana  46267
Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer CenterIndianapolis, Indiana  46202
Boston University Medical Center HospitalBoston, Massachusetts  02118
Minnesota Oncology/Hematology, PABurnsville, Minnesota  55337
Minnesota Oncology/Hematology Associates of Central IllinoisMinneapolis, Minnesota  55404
Metro-MN CCOPSt. Louis Park, Minnesota  55416
The West ClinicCorinth, Mississippi  38834
St. Luke's Hospital of Kansas City/St. Luke's Cancer InstituteKansas City, Missouri  64111
Southeast Nebraska Oncology/Southeast Nebraska Cancer CenterLincoln, Nebraska  68510
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Hematology and Oncology Associates of Northern New JerseyMorristown, New Jersey  07962
University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew JerseyNew Brunswick, New Jersey  07090
Schwartz Gynecologic Oncology, PLLCBabylon, New York  11702
Bellview HospitalNew York, New York  10016
New York University School of Medicine/NYU Cancer InstituteNew York, New York  10016
St. Vincent Catholic Medical Center of New YorkStaten Island, New York  10310
New Hanover Regional Medical Center/Zimmer Cancer CenterWilmington, North Carolina  28401
Camelot Women's CancerColumbus, Ohio  43214
The Arthur G. James Cancer HospitalColumbus, Ohio  43214
Oncology Associates of Oregon, PC/Willaimette Valley Cancer CenterEugene, Oregon  97401-8122
Northwest Cancer Specialists, P.C.Portland, Oregon  97227
Magee - Women's HospitalPittsburgh, Pennsylvania  15213
GYN Oncology Research/Gynecologic Oncology Research & Development, LLCGreenville, South Carolina  29601
Hall and Martin MDs, PCKnoxville, Tennessee  37920
Cancer Care Center of South TexasSan Antonio, Texas  78229
Virginia Commonwealth University/VCU Massey Cancer CenterRichmond, Virginia  23298
Gersh, RobertSpokane, Washington  99202
Aurora Medical Gyn GroupWest Allis, Wisconsin  53227