Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00262990
Collaborator
(none)
829
149
2
5.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
829 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Nov 1, 2005
Actual Primary Completion Date
:
Feb 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patupilone
|
Drug: EPO906 (Patupilone)
Other Names:
|
| Active Comparator: doxorubicin
|
Drug: doxorubicin
|
Outcome Measures
Primary Outcome Measures
- To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer [every 8 weeks]
Secondary Outcome Measures
- To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD) [End of study]
- To determine the progression-free survival (PFS) of patients treated with patupilone [end of study]
- To determine the time to disease progression (TTP) of patients treated with patupilone [end of study]
- To determine overall best tumor response (CR, PR, SD, PD and Unknown) [end of study]
- To investigate the safety and tolerability of patupilone [end of study]
- To evaluate the pharmacokinetics (PK) of patupilone from all patients [end of study]
- To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events [end of study]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Cancer Research & Education Center | Anchorage | Alaska | United States | 99508 |
| 2 | Northern Arizona Hematology & Oncology Associates | Flagstaff | Arizona | United States | 86001 |
| 3 | Mayo Center for Women's Health | Scottsdale | Arizona | United States | 85259 |
| 4 | Northern Arizona Hematology & Oncology Associates | Sedona | Arizona | United States | 86336 |
| 5 | Genesis Cancer Center | Hot Springs | Arkansas | United States | 71913 |
| 6 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 7 | Yanagihara, Ronald H. | Gilroy | California | United States | 95020 |
| 8 | California Cancer Care, Inc. | Greenbrae | California | United States | 94904 |
| 9 | University of California - San Diego/ Moores Cancer Center | La Jolla | California | United States | 92093-0987 |
| 10 | LAC & USC Women's & Children's Hospital | Los Angeles | California | United States | 90033 |
| 11 | Gynecologic Oncology associates | Newport Beach | California | United States | 92663 |
| 12 | UC Davis Cancer Center | Sacramento | California | United States | 95817 |
| 13 | California Pacific Medical Center Research Institute | San Francisco | California | United States | 94115 |
| 14 | Anschutz Cancer Pavilion | Aurora | Colorado | United States | 80045 |
| 15 | Anschutz Cancer Pavilion - Clinical Investigations Core | Aurora | Colorado | United States | 90045 |
| 16 | University Of Colorado Health Sciences Center | Denver | Colorado | United States | 80262 |
| 17 | Yale University School of Medicine | New Haven | Connecticut | United States | 06520 |
| 18 | Christiana Gynecologic Oncology, LLC | Newark | Delaware | United States | 19713 |
| 19 | Washington Hospital Center/Medstar Research Institute | Washington | District of Columbia | United States | 20010-2931 |
| 20 | Florida Gynecologic Oncology | Fort Myers | Florida | United States | 33901 |
| 21 | Miami Cancer Center at Mercy Hospital | Miami | Florida | United States | 33133 |
| 22 | Miami Cancer Center at University Hospital | Miami | Florida | United States | 33133 |
| 23 | University of Miami | Miami | Florida | United States | 33136 |
| 24 | Mt. Sinai Medical Center | Miami | Florida | United States | 33143 |
| 25 | Advanced Medical Specialties | Miami | Florida | United States | 33176 |
| 26 | Ocala Oncology Center | Ocala | Florida | United States | 34471 |
| 27 | MD Anderson Cancer Center of Orlando | Orlando | Florida | United States | 32806 |
| 28 | Oncology & Hematology Associates of West Broward | Tamarac | Florida | United States | 33321 |
| 29 | Xelero Medical Research/Giselle Ghurani | Tampa | Florida | United States | 33607 |
| 30 | Medical College of Georgia | Augusta | Georgia | United States | 30912 |
| 31 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 32 | Kapiolani Medical Center for Women and Children/Univ. of HI | Honolulu | Hawaii | United States | 96826 |
| 33 | Northwest Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 34 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 35 | Cancer Institute of Central Illinois/Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 36 | Indiana University Obstetrics | Indianapolis | Indiana | United States | 00144 |
| 37 | Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 38 | Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation | Indianapolis | Indiana | United States | 46267 |
| 39 | Northern Indiana Cancer Research Consortium | South Bend | Indiana | United States | 46617 |
| 40 | Louisville Oncology | Louisville | Kentucky | United States | 40202 |
| 41 | Franklin Square Hospital Center | Baltimore | Maryland | United States | 21237 |
| 42 | Boston University Medical Center Hospital | Boston | Massachusetts | United States | 02118 |
| 43 | Providence Cancer Center | Southfield | Michigan | United States | 48075 |
| 44 | Minnesota Oncology/Hematology, PA | Burnsville | Minnesota | United States | 55337 |
| 45 | St. Luke's Hospital | Duluth | Minnesota | United States | 55805 |
| 46 | Minnesota Oncology/Hematology, PA | Edina | Minnesota | United States | 55435 |
| 47 | Minnesota Oncology/Hematology Associates of Central Illinois | Minneapolis | Minnesota | United States | 55404 |
| 48 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 49 | Metro-MN CCOP | Saint Louis Park | Minnesota | United States | 55416 |
| 50 | Minnesota Oncology Hematology | Saint Paul | Minnesota | United States | 55102-2389 |
| 51 | The West Clinic | Corinth | Mississippi | United States | 38834 |
| 52 | The West Clinic | Southaven | Mississippi | United States | 38671 |
| 53 | St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute | Kansas City | Missouri | United States | 64111 |
| 54 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 55 | Southeast Nebraska Oncology/Southeast Nebraska Cancer Center | Lincoln | Nebraska | United States | 68510 |
| 56 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89109 |
| 57 | Women's Cancer Center of Nevada | Las Vegas | Nevada | United States | 89109 |
| 58 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 59 | Hematology and Oncology Associates of Northern New Jersey | Morristown | New Jersey | United States | 07962 |
| 60 | University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey | New Brunswick | New Jersey | United States | 07090 |
| 61 | New York Oncology Hematology, P.C. | Albany | New York | United States | 12208 |
| 62 | Schwartz Gynecologic Oncology, PLLC | Babylon | New York | United States | 11702 |
| 63 | Bellview Hospital | New York | New York | United States | 10016 |
| 64 | New York University School of Medicine/NYU Cancer Institute | New York | New York | United States | 10016 |
| 65 | NYU Cancer Institute | New York | New York | United States | 10016 |
| 66 | St. Vincent Catholic Medical Center of New York | Staten Island | New York | United States | 10310 |
| 67 | Brody School of Medicine | Greenville | North Carolina | United States | 27834 |
| 68 | New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington | North Carolina | United States | 28401 |
| 69 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210-1228 |
| 70 | Camelot Women's Cancer | Columbus | Ohio | United States | 43214 |
| 71 | The Arthur G. James Cancer Hospital | Columbus | Ohio | United States | 43214 |
| 72 | Cancer Care Associates | Tulsa | Oklahoma | United States | 74136 |
| 73 | Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center | Eugene | Oregon | United States | 97401-8122 |
| 74 | Northwest Cancer Specialists, P.C. | Portland | Oregon | United States | 97227 |
| 75 | Willamette Valley Cancer Center | Springfield | Oregon | United States | 97477 |
| 76 | Medical Oncology Associates of Wyoming Valley, PC | Kingston | Pennsylvania | United States | 18704 |
| 77 | Magee - Women's Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 78 | GYN Oncology Research/Gynecologic Oncology Research & Development, LLC | Greenville | South Carolina | United States | 29601 |
| 79 | Chattanooga GYN Oncology | Chattanooga | Tennessee | United States | 37403 |
| 80 | Hall and Martin MDs, PC | Knoxville | Tennessee | United States | 37920 |
| 81 | The West Clinic | Memphis | Tennessee | United States | 38104 |
| 82 | West Clinic | Memphis | Tennessee | United States | 38120 |
| 83 | Texas Oncology, P.A. | Austin | Texas | United States | 78731 |
| 84 | Texas Oncology | Austin | Texas | United States | 78745 |
| 85 | Texas Oncology, P.A. | Bedford | Texas | United States | 76022 |
| 86 | Texas Oncology, P.A. | Dallas | Texas | United States | 75231 |
| 87 | Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 88 | Texas Oncology, P.A. | Dallas | Texas | United States | 75246 |
| 89 | Texas Oncology, P.A. | Fort Worth | Texas | United States | 76104 |
| 90 | Oncology Consultants P.A. | Houston | Texas | United States | 77024 |
| 91 | Cancer Care Center of South Texas | San Antonio | Texas | United States | 78229 |
| 92 | Waco Cancer Care & Research Center | Waco | Texas | United States | 76712 |
| 93 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84106 |
| 94 | Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
| 95 | Cancer Outreach Associates | Abingdon | Virginia | United States | 24211 |
| 96 | Northern Virginia Pelvic Surgery Associates | Annandale | Virginia | United States | 22003 |
| 97 | Virginia Oncology Associates | Newport News | Virginia | United States | 23606 |
| 98 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
| 99 | Virginia Commonwealth University/VCU Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 100 | Gersh, Robert | Spokane | Washington | United States | 99202 |
| 101 | Northwest Cancer Specialists, P.C. | Vancouver | Washington | United States | 98664 |
| 102 | Northwest Cancer Specialists | Vancouver | Washington | United States | 98664 |
| 103 | Yakima Valley Memorial Hospital | Yakima | Washington | United States | 98902 |
| 104 | Aurora Medical Gyn Group | West Allis | Wisconsin | United States | 53227 |
| 105 | Novartis Investigative Site | Adelaide | Australia | ||
| 106 | Novartis Investigative Site | Herston | Australia | ||
| 107 | Novartis Investigative Site | Nedlands, WA | Australia | ||
| 108 | Novartis Investigative Site | South Brisbane | Australia | ||
| 109 | Novartis Investigative Site | St. Leonards | Australia | ||
| 110 | Novartis Investigative Site | Wodonga | Australia | ||
| 111 | BC Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 112 | Novartis Investigative Site | Calgary | Canada | ||
| 113 | Novartis Investigative Site | Montreal | Canada | ||
| 114 | Novartis Investigative Site | North York | Canada | ||
| 115 | Novartis Investigative Site | Quebec | Canada | ||
| 116 | Novartis Investigative Site | Sherbrooke | Canada | ||
| 117 | Novartis Investigative Site | Toronto | Canada | M5G 2M9 | |
| 118 | Novartis Investigative Site | Odense | Denmark | ||
| 119 | Novartis Investigative Site | Vejle | Denmark | ||
| 120 | Novartis Investigative Site | Helsinki | Finland | ||
| 121 | Novartis Investigative Site | Kuopio | Finland | ||
| 122 | Novartis Investigative Site | Tampere | Finland | ||
| 123 | Novartis Investigative Site | Amboise | France | ||
| 124 | Novartis Investigative Site | Bordeaux | France | ||
| 125 | Novartis Investigative Site | Caen Cedex | France | ||
| 126 | Novartis Investigative Site | Herblain Cedec | France | ||
| 127 | Novartis Investigative Site | Villejuif Cedex | France | ||
| 128 | Novartis Investigative Site | Athens | Greece | ||
| 129 | Novartis Investigative Site | Bologna | Italy | ||
| 130 | Novartis Investigative Site | Milano | Italy | ||
| 131 | Novartis Investigative Site | Modena | Italy | ||
| 132 | Novartis Investigative Site | Monza | Italy | ||
| 133 | Novartis Investigative Site | Padova | Italy | ||
| 134 | Novartis Investigative Site | Roma | Italy | ||
| 135 | Novartis Investigative Site | Torino | Italy | ||
| 136 | Novartis Investigative Site | Krakow | Poland | ||
| 137 | Novartis Investigative Site | Cape Town | South Africa | ||
| 138 | Novartis Investigative Site | Johannesburg, Gauteng | South Africa | ||
| 139 | Novartis Investigative Site | Klerksdorp | South Africa | ||
| 140 | Novartis Investigative Site | Port Elizabeth | South Africa | ||
| 141 | Novartis Investigative Site | Pretoria, Gauteng | South Africa | ||
| 142 | Novartis Investigative Site | Pretoria, Guateng | South Africa | ||
| 143 | Novartis Investigative Site | Sandton, Gauteng | South Africa | ||
| 144 | Novartis Investigative Site | Barcelona | Spain | ||
| 145 | Novartis Investigative Site | Madrid | Spain | ||
| 146 | Novartis Investigative Site | Glasgow | United Kingdom | ||
| 147 | Novartis Investigative Site | London | United Kingdom | ||
| 148 | Novartis Investigative Site | Wirral | United Kingdom | ||
| 149 | Novartis Investigative Site | Wolverhampton | United Kingdom |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- In the search box enter NCT00262990
- Select "Ovarian Cancer"
- Results for CEPO906A2303 from the Novartis Clinical Trials website
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00262990
Other Study ID Numbers:
- CEPO906A2303
First Posted:
Dec 7, 2005
Last Update Posted:
Dec 17, 2020
Last Verified:
May 1, 2012
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: