Clinical trial NCT00262990: Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Keywords: Epithelial ovarian cancer
fallopian tube cancer
peritoneal cancer
primary cancer
recurrent cancer
doxorubicin
taxane chemotherapy
platinum chemotherapy
Patupilone
taxane platinum resistant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-07
Enrollment: 829
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
timeFrame: every 8 weeks
Secondary outcomes:
measure: To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)
timeFrame: End of study
measure: To determine the progression-free survival (PFS) of patients treated with patupilone
timeFrame: end of study
measure: To determine the time to disease progression (TTP) of patients treated with patupilone
timeFrame: end of study
measure: To determine overall best tumor response (CR, PR, SD, PD and Unknown)
timeFrame: end of study
measure: To investigate the safety and tolerability of patupilone
timeFrame: end of study
measure: To evaluate the pharmacokinetics (PK) of patupilone from all patients
timeFrame: end of study
measure: To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events
timeFrame: end of study
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Cancer Research & Education Center
state: Alaska
city: Flagstaff
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Center for Women's Health
state: Arizona
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Gilroy
country: United States
facility: Yanagihara, Ronald H.
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: La Jolla
country: United States
facility: University of California - San Diego/ Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: LAC & USC Women's & Children's Hospital
state: California
city: Newport Beach
country: United States
facility: Gynecologic Oncology associates
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion - Clinical Investigations Core
state: Colorado
city: Denver
country: United States
facility: University Of Colorado Health Sciences Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Newark
country: United States
facility: Christiana Gynecologic Oncology, LLC
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center/Medstar Research Institute
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Gynecologic Oncology
state: Florida
city: Miami
country: United States
facility: Miami Cancer Center at Mercy Hospital
state: Florida
city: Miami
country: United States
facility: Miami Cancer Center at University Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Mt. Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center of Orlando
state: Florida
city: Tamarac
country: United States
facility: Oncology & Hematology Associates of West Broward
state: Florida
city: Tampa
country: United States
facility: Xelero Medical Research/Giselle Ghurani
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children/Univ. of HI
state: Hawaii
city: Chicago
country: United States
facility: Northwest Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Decatur
country: United States
facility: Cancer Institute of Central Illinois/Decatur Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Obstetrics
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Louisville
country: United States
facility: Louisville Oncology
state: Kentucky
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center Hospital
state: Massachusetts
city: Southfield
country: United States
facility: Providence Cancer Center
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology/Hematology, PA
state: Minnesota
city: Duluth
country: United States
facility: St. Luke's Hospital
state: Minnesota
city: Edina
country: United States
facility: Minnesota Oncology/Hematology, PA
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology/Hematology Associates of Central Illinois
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro-MN CCOP
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Corinth
country: United States
facility: The West Clinic
state: Mississippi
city: Southaven
country: United States
facility: The West Clinic
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Oncology/Southeast Nebraska Cancer Center
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Hematology and Oncology Associates of Northern New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Babylon
country: United States
facility: Schwartz Gynecologic Oncology, PLLC
state: New York
city: New York
country: United States
facility: Bellview Hospital
state: New York
city: New York
country: United States
facility: New York University School of Medicine/NYU Cancer Institute
state: New York
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
city: Staten Island
country: United States
facility: St. Vincent Catholic Medical Center of New York
state: New York
city: Greenville
country: United States
facility: Brody School of Medicine
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center/Zimmer Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Camelot Women's Cancer
state: Ohio
city: Columbus
country: United States
facility: The Arthur G. James Cancer Hospital
state: Ohio
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Springfield
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates of Wyoming Valley, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee - Women's Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: GYN Oncology Research/Gynecologic Oncology Research & Development, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga GYN Oncology
state: Tennessee
city: Knoxville
country: United States
facility: Hall and Martin MDs, PC
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Memphis
country: United States
facility: West Clinic
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: Oncology Consultants P.A.
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Center of South Texas
state: Texas
city: Waco
country: United States
facility: Waco Cancer Care & Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Abingdon
country: United States
facility: Cancer Outreach Associates
state: Virginia
city: Annandale
country: United States
facility: Northern Virginia Pelvic Surgery Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/VCU Massey Cancer Center
state: Virginia
city: Spokane
country: United States
facility: Gersh, Robert
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
city: West Allis
country: United States
facility: Aurora Medical Gyn Group
state: Wisconsin
city: Adelaide
country: Australia
facility: Novartis Investigative Site
city: Herston
country: Australia
facility: Novartis Investigative Site
city: Nedlands, WA
country: Australia
facility: Novartis Investigative Site
city: South Brisbane
country: Australia
facility: Novartis Investigative Site
city: St. Leonards
country: Australia
facility: Novartis Investigative Site
city: Wodonga
country: Australia
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Calgary
country: Canada
facility: Novartis Investigative Site
city: Montreal
country: Canada
facility: Novartis Investigative Site
city: North York
country: Canada
facility: Novartis Investigative Site
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
city: Odense
country: Denmark
facility: Novartis Investigative Site
city: Vejle
country: Denmark
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Amboise
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Caen Cedex
country: France
facility: Novartis Investigative Site
city: Herblain Cedec
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Modena
country: Italy
facility: Novartis Investigative Site
city: Monza
country: Italy
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg, Gauteng
country: South Africa
facility: Novartis Investigative Site
city: Klerksdorp
country: South Africa
facility: Novartis Investigative Site
city: Port Elizabeth
country: South Africa
facility: Novartis Investigative Site
city: Pretoria, Gauteng
country: South Africa
facility: Novartis Investigative Site
city: Pretoria, Guateng
country: South Africa
facility: Novartis Investigative Site
city: Sandton, Gauteng
country: South Africa
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Wirral
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Colombo N, Kutarska E, Dimopoulos M, Bae DS, Rzepka-Gorska I, Bidzinski M, Scambia G, Engelholm SA, Joly F, Weber D, El-Hashimy M, Li J, Souami F, Wing P, Engelholm S, Bamias A, Schwartz P. Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. J Clin Oncol. 2012 Nov 1;30(31):3841-7. doi: 10.1200/JCO.2011.38.8082. Epub 2012 Sep 17.