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NCT00262990 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00262990
Other study ID # CEPO906A2303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2005

Study information
Verified date May 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 829
Est. completion date
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• EPO906 (Patupilone)

• doxorubicin

Locations
Country Name City State
Australia 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
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 BC Cancer Agency Vancouver British Columbia
Denmark Novartis Investigative Site Odense
Denmark Novartis Investigative Site Vejle
Finland Novartis Investigative Site Helsinki
Finland Novartis Investigative Site Kuopio
Finland Novartis Investigative Site Tampere
France 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
Greece Novartis Investigative Site Athens
Italy 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
Poland Novartis Investigative Site Krakow
South Africa 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
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Madrid
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Wirral
United Kingdom Novartis Investigative Site Wolverhampton
United States Cancer Outreach Associates Abingdon Virginia
United States New York Oncology Hematology, P.C. Albany New York
United States Alaska Cancer Research & Education Center Anchorage Alaska
United States Northern Virginia Pelvic Surgery Associates Annandale Virginia
United States Medical College of Georgia Augusta Georgia
United States Anschutz Cancer Pavilion Aurora Colorado
United States Anschutz Cancer Pavilion - Clinical Investigations Core Aurora Colorado
United States Texas Oncology Austin Texas
United States Texas Oncology, P.A. Austin Texas
United States Schwartz Gynecologic Oncology, PLLC Babylon New York
United States Franklin Square Hospital Center Baltimore Maryland
United States Texas Oncology, P.A. Bedford Texas
United States Boston University Medical Center Hospital Boston Massachusetts
United States Fletcher Allen Health Care Burlington Vermont
United States Minnesota Oncology/Hematology, PA Burnsville Minnesota
United States Chattanooga GYN Oncology Chattanooga Tennessee
United States Northwest Memorial Hospital Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Camelot Women's Cancer Columbus Ohio
United States Ohio State University Medical Center Columbus Ohio
United States The Arthur G. James Cancer Hospital Columbus Ohio
United States The West Clinic Corinth Mississippi
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 Cancer Institute of Central Illinois/Decatur Memorial Hospital Decatur Illinois
United States University Of Colorado Health Sciences Center Denver Colorado
United States St. Luke's Hospital Duluth Minnesota
United States Minnesota Oncology/Hematology, PA Edina Minnesota
United States Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center Eugene Oregon
United States Northern Arizona Hematology & Oncology Associates Flagstaff Arizona
United States Florida Gynecologic Oncology Fort Myers Florida
United States Texas Oncology, P.A. Fort Worth Texas
United States Yanagihara, Ronald H. Gilroy California
United States California Cancer Care, Inc. Greenbrae California
United States Brody School of Medicine Greenville North Carolina
United States GYN Oncology Research/Gynecologic Oncology Research & Development, LLC Greenville South Carolina
United States Kapiolani Medical Center for Women and Children/Univ. of HI Honolulu Hawaii
United States Genesis Cancer Center Hot Springs Arkansas
United States Oncology Consultants P.A. Houston Texas
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 Indiana University Obstetrics Indianapolis Indiana
United States St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute Kansas City Missouri
United States Medical Oncology Associates of Wyoming Valley, PC Kingston Pennsylvania
United States Hall and Martin MDs, PC Knoxville Tennessee
United States University of California - San Diego/ Moores Cancer Center La Jolla California
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 Southeast Nebraska Oncology/Southeast Nebraska Cancer Center Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States LAC & USC Women's & Children's Hospital Los Angeles California
United States Louisville Oncology Louisville Kentucky
United States The West Clinic Memphis Tennessee
United States West Clinic Memphis Tennessee
United States Advanced Medical Specialties Miami Florida
United States Miami Cancer Center at Mercy Hospital Miami Florida
United States Miami Cancer Center at University Hospital Miami Florida
United States Mt. Sinai Medical Center Miami Florida
United States University of Miami Miami Florida
United States Minnesota Oncology/Hematology Associates of Central Illinois Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
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 Yale University School of Medicine New Haven Connecticut
United States Bellview Hospital New York New York
United States New York University School of Medicine/NYU Cancer Institute New York New York
United States NYU Cancer Institute New York New York
United States Christiana Gynecologic Oncology, LLC Newark Delaware
United States Gynecologic Oncology associates Newport Beach California
United States Virginia Oncology Associates Newport News Virginia
United States Virginia Oncology Associates Norfolk Virginia
United States Ocala Oncology Center Ocala Florida
United States MD Anderson Cancer Center of Orlando Orlando Florida
United States Magee - Women's Hospital Pittsburgh Pennsylvania
United States Northwest Cancer Specialists, P.C. Portland Oregon
United States Virginia Commonwealth University/VCU Massey Cancer Center Richmond Virginia
United States UC Davis Cancer Center Sacramento California
United States Washington University School of Medicine Saint Louis Missouri
United States Metro-MN CCOP Saint Louis Park Minnesota
United States Minnesota Oncology Hematology Saint Paul Minnesota
United States Utah Cancer Specialists Salt Lake City Utah
United States Cancer Care Center of South Texas San Antonio Texas
United States California Pacific Medical Center Research Institute San Francisco California
United States Memorial Health University Medical Center Savannah Georgia
United States Mayo Center for Women's Health Scottsdale Arizona
United States Northern Arizona Hematology & Oncology Associates Sedona Arizona
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States The West Clinic Southaven Mississippi
United States Providence Cancer Center Southfield Michigan
United States Gersh, Robert Spokane Washington
United States Willamette Valley Cancer Center Springfield Oregon
United States St. Vincent Catholic Medical Center of New York Staten Island New York
United States Oncology & Hematology Associates of West Broward Tamarac Florida
United States Xelero Medical Research/Giselle Ghurani Tampa Florida
United States Cancer Care Associates Tulsa Oklahoma
United States Northwest Cancer Specialists Vancouver Washington
United States Northwest Cancer Specialists, P.C. Vancouver Washington
United States Waco Cancer Care & Research Center Waco Texas
United States Washington Hospital Center/Medstar Research Institute Washington District of Columbia
United States Aurora Medical Gyn Group West Allis Wisconsin
United States New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina
United States Yakima Valley Memorial Hospital Yakima Washington

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Finland,  France,  Greece,  Italy,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer every 8 weeks
Secondary To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD) End of study
Secondary To determine the progression-free survival (PFS) of patients treated with patupilone end of study
Secondary To determine the time to disease progression (TTP) of patients treated with patupilone end of study
Secondary To determine overall best tumor response (CR, PR, SD, PD and Unknown) end of study
Secondary To investigate the safety and tolerability of patupilone end of study
Secondary To evaluate the pharmacokinetics (PK) of patupilone from all patients end of study
Secondary To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events end of study
See also
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Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
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Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2

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