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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


Pharmaceutical / Industry


CEPO906A2303
NCT00262990

Trial Description

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

NovartisStudy Chair

NovartisPh: 1-800-340-6843

Trial Sites

U.S.A.
Alaska
  Anchorage
 Katmai Oncology Group
 Ericka Kramer Ph: 907-868-8009
  Email: erickac@acrec.org
 Jeanne E. AndersonPrincipal Investigator
Arizona
  Flagstaff
 Northern Arizona Hematology & Oncology Associates
 Janice Miller Ph: 928-773-2260
  Email: janice.miller@usoncology.com
 Deborah Lindquist, M.D.Principal Investigator
  Sedona
 Northern Arizona Hematology and Oncology Associates - Sedona
 Karen Freriks Ph: 928-204-4198
  Email: karen.freriks@usoncology.com
 Deborah Lindquist, Dr.Principal Investigator
California
  Greenbrae
 California Cancer Care, Incorporated - Greenbrae
 Jamie Chang Ph: 415-925-5040
  Email: jchang@cal-cancer-care.com
 Peter D. EisenbergPrincipal Investigator
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Steven Plaxe, MDPrincipal Investigator
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Grace Facio Ph: 323-226-3398
  Email: gfacio@ccnt.hsc.usc.edu
 Huyen Pham, M.D.Principal Investigator
  Sacramento
 University of California Davis Cancer Center
 Karen Schlaier Ph: 916-734-8814
  Email: Karen.Schlaier@ucdmc.ucdavis.edu
 Sidney Scudder, M.D.Principal Investigator
Colorado
  Denver
 University of Colorado Cancer Center at UC Health Sciences Center
 Gayle Lundblad Ph: 720-848-0363
  Email: Gayle.Lundblad@uchsc.edu
 Sidney McIntosh Ph: 1 720 8480681
  Email: sidney.McIntosh@UCHSC.edu
 Kian Behbakht, M.D.Principal Investigator
Connecticut
  New Haven
 Yale Cancer Center
 Lisa Baker Ph: 203-785-6398
  Email: lisa.baker@yale.edu
 Peter SchwartzPrincipal Investigator
District of Columbia
  Washington
 Washington Cancer Institute at Washington Hospital Center
 Velega Roberts Ph: 202-877-8517
  Email: velega.e.roberts@medstar.net
 Jonathan Cosin, Dr.Principal Investigator
Florida
  Fort Myers
 Florida Gynecologic Oncology - Fort Myers
 Cindy Armentano
  Email: carmenta@rtsx.com
 Edward Grendys, M.D.Principal Investigator
Georgia
  Augusta
 Medical College of Georgia Cancer Center
 Sara Mobley Ph: 706-721-4805
  Email: smobley@mail.mcg.edu
 Sharad Ghamande, M.D.Principal Investigator
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 Joni Short Ph: 912-350-8913
  Email: Shortjo1@memorialhealth.com
 James Burke, M.D.Principal Investigator
Hawaii
  Honolulu
 Kapiolani Medical Center for Women and Children
 Felix Militante Ph: 808-983-8747
  Email: felix.militante@wilcoxhealth.org
 Michael Carney, M.D.Principal Investigator
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Doreine Carson Ph: 312-472-4681
  Email: d-carson@northwestern.edu
 Diljeet K. SinghPrincipal Investigator
 Rush Cancer Institute at Rush University Medical Center
 Linda Polzin Ph: 312-942-3608
  Email: Linda_K_Polzin@rush.edu
 Lydia UshaPrincipal Investigator
  Decatur
 Cancer Institute of Central Illinois
 Terri Eller Ph: 217-876-6614
  Email: terrib@dmhhs.org
 James Wade, M.D.Principal Investigator
Indiana
  Indianapolis
 Gynecologic Oncology of Indiana
 Reba Baker Ph: 317-782-7060
  Email: reba.baker@ssfhs.edu
 Linda Frazier Ph: 1 317 7827822
  Email: Linda.Frazier@ssfhs.org
 David Moore, M.D.Principal Investigator
  South Bend
 CCOP - Northern Indiana CR Consortium
 Lisa Barnaby Ph: 574-237-7784
  Email: barnabyl@sjrmc.com
 Michael Method, M.D.Principal Investigator
Kentucky
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Cheri Blincoe Ph: 502-629-5315
  Email: sharon.blincoe@nortonhealthcare.org
 Jeffrey Goldberg, M.D.Principal Investigator
Massachusetts
  Boston
 Boston University Cancer Research Center
 Salli Fennessey Ph: 617-638-8261
  Email: sfenness@bu.edu
 Rita Blanchard, M.D.Principal Investigator
Minnesota
  Duluth
 St. Luke's Hospital Cancer Care Center
 Lyn Winson Ph: 218-249-5337
  Email: LWinson@slhduluth.com
 Tanya Repka, M.D.Principal Investigator
  Edina
 Minnesota Oncology/Hematology Associates of Central Illinois
 Kari Hurley Ph: 952-892-7190
  Email: kari.hurley@usoncology.com
 Patrick Flynn, M.D.Principal Investigator
  Minneapolis
 Masonic Cancer Center at University of Minnesota
 Ann Harper Ph: 612-624-0735
  Email: hoppe147@umn.edu
 Ashley Schempp Ph: 1 612 6265174
  Email: john3587@umn.edu
 Peter Argenta, Dr.Principal Investigator
 Minnesota Oncology Hematology, PA - Minneapolis
 Stephanie Erickson Ph: 952-928-2900
  Email: stephanie.erickson@usoncology.com
 Patrick Flynn, Dr.Principal Investigator
  St. Paul
 Minnesota Oncology Hematology, PA - St. Paul
 Bridget Holman Ph: 651-602-5200
  Email: bridget.holman@usoncology.com
 Patrick Flynn, M.D.Principal Investigator
Missouri
  Kansas City
 Saint Luke's Cancer Institute at Saint Luke's Hospital
 Sue Latham Ph: 816-932-1349
  Email: slatham@saint-lukes.org
 Lowell J. ByersPrincipal Investigator
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Lynne Lippmann Ph: 314-362-1760
  Email: lippmannl@msnotes.wustl.edu
 Donna Dombrowski Ph: 1 314 3621760
  Email: dombrowskid@msnotes.wustl.edu
 David Mutch, M.D.Principal Investigator
Nebraska
  Lincoln
 Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center
 Tracy Christianson Ph: 402-327-7363
  Email: TracyC@senhoc.com
 Alan Berg, Dr.Principal Investigator
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Elizabeth Bergman Ph: 702-851-4672
  Email: ebergman@wccenter.com
 Danielle Turner Ph: +1-702-851-4672
  Email: o_d_turner@hotmail.com
 Nicola Spirtos, M.D.Principal Investigator
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Kathy Phipps Ph: 603-653-3537
  Email: Kathy.J.Phipps@Dartmouth.edu
 Leslie DeMars, M.D.Principal Investigator
New Jersey
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Dama Bhavsar Ph: 732-235-4943
  Email: bhavsadm@umdnj.edu
 Andrea Hugill Ph: 732 235 8972
  Email: hugillan@umdnj.edu
 Darlene Gibbon, M.D.Principal Investigator
New York
  Babylon
 Schwartz Oncology
 Jaclyn Frizalone Ph: 631-376-0055
  Email: jf@schwartzoncology.com
 Debolina Kowshik Ph: 1 631 8941032
  Email: dk@schwartzoncology.com
 Benjamin Schwartz, M.D.Principal Investigator
  Staten Island
 St. Vincent's Comprehensive Cancer Center - Manhattan
 Marion Smith Ph: 718-818-1024
  Email: marismith@rumcsi.org
 Thomas Forlenza, M.D.Principal Investigator
North Carolina
  Greenville
 Brody School of Medicine at East Carolina University
 Melinda Friday Ph: 252-744-1015
  Email: fridaym@ecu.edu
 Howard Homesley, Dr.Principal Investigator
  Wilmington
 New Hanover Regional Medical Center
 Roxan Brock Ph: 910-343-4013
  Email: roxan.brock@nhhn.org
 Monique Harris Ph: 1 910 3434078
  Email: Monique.Harris@nhhn.org
 Walter Gajewski, Dr.Principal Investigator
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
 Michele Vaughn Ph: 614-442-3101
  Email: michele.vaughan@osumc.edu
 Shannon Thompson Ph: 614 4420058
  Email: Shannon.Thompson@osumc.edu
 David O'Malley, Dr.Principal Investigator
Oregon
  Eugene
 Oncology Associates of Oregon, PC
 Cynthia Cabrera Ph: 541-681-4930
  Email: cynthia.cabrera@usoncology.com
 Glenn Buchanan, Dr.Principal Investigator
  Portland
 Northwest Cancer Specialists - Northwest Office
 Jolene Kemp Ph: 503-231-2612
  Email: jolene.kemp@usoncology.com
 Robin Doyle Ph: 1 503 5285002
  Email: Robin.Doyle@usoncology.com
 David A. SmithPrincipal Investigator
 Northwest Cancer Specialists at Rose Quarter Cancer Center
 Jennifer Thompson Ph: 503-528-5005
  Email: jennifer.thompson@usoncology.com
 David A. SmithPrincipal Investigator
  Springfield
 Willamette Valley Cancer Center - Springfield
 Lisa Cone Ph: 541-868-2543
  Email: lisa.cone@usoncology.com
 Glenn Buchanan, M.D.Principal Investigator
Pennsylvania
  Pittsburgh
 UPMC Cancer Center at Magee-Womens Hospital
 Kathy Bukauskas Ph: 412-641-3133
  Email: bukauskaska@upmc.edu
 Robert P. EdwardsPrincipal Investigator
 Vicki Gilchrist Ph: 412-641-4365
  Email: gilchristvb@upmc.edu
 Robert P. EdwardsPrincipal Investigator
Tennessee
  Knoxville
 Hall and Martin, M.Ds., PC
 Rhonda Snyder Ph: 865-632-5206
  Email: rsnyder@mercy.com
 David Martin, M.D.Principal Investigator
  Memphis
 West Clinic - East Memphis
 Tracey Stewart Ph: 901-683-0055
  Email: tstewart@westclinic.com
 Aneda Bebee Ph: 1 662 286 3694
  Email: abebee@westclinic.com
 Joseph Santoso, M.D.Principal Investigator
Texas
  Austin
 Texas Oncology, PA at Texas Oncology Cancer Center - Central
 Gabriella Iannone Ph: 512-427-9467
  Email: gabriella.iannone@usoncology.com
 Michael Teneriello, Dr.Principal Investigator
  Bedford
 Texas Oncology, PA at Harris Center HEB
 Cindi Schoenfeldt Ph: 817-359-9033
  Email: cynthia.schoenfeldt@usoncology.com
 Mark Messing, M.D.Principal Investigator
  Dallas
 Charles A. Sammons Cancer Center
 Marnie Fisher Ph: 214-370-1038
  Email: marnie.fisher@usoncology.com
 Rita Lopez Ph: 214 370 1846
  Email: rita.lopez2@usoncology.com
 Eric Koon, M.D.Principal Investigator
  Waco
 Waco Cancer Care
 Theresa Schroeder Ph: 254-399-0741
  Email: theresa.schroeder@usoncology.com
 Robert AndersonPrincipal Investigator
Utah
  Salt Lake City
 Utah Cancer Specialists at UCS Cancer Center
 Johnny Walker Ph: 801-281-6864
  Email: jwalker@utahcancer.com
 William Harker, M.D.Principal Investigator
Vermont
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Kimberley Spina Ph: 802-847-5110
  Email: Kimberly.Spina@vtmednet.org
 Erica Nuzzo Ph: 1 802 8473453
  Email: Erica.Nuzzo@med.uvm.edu
 Cheung Wong, Dr.Principal Investigator
Virginia
  Abingdon
 Cancer Outreach Associates - Abingdon
 Karen Taylor Ph: 276-676-1863
  Email: ktaylor@canceroutreach.com
 Patsy Spears Ph: 276 676 1870
  Email: pspears@canceroutrearch.com
 Forrest Swan, Dr.Principal Investigator
  Annandale
 Northern Virginia Pelvic Surgery Associates
 Sheila Whitt Ph: 703-698-7100
  Email: swhitt@nvpsa.net
 Annette Bicher, M.D.Principal Investigator
  Newport News
 Virginia Oncology Associates - Newport News
 Helen Clark Ph: 757-873-9833
  Email: helen.clark@usoncology.com
 Stacy Fickbohm Ph: 1 757 2135615
  Email: stacy.fickbohm@usoncology.com
 Paul R. ConklingPrincipal Investigator
  Norfolk
 Virginia Oncology Associates - Lake Wright
 Shelly Pilley Ph: 757-873-9400
  Email: shelly.pilley@usoncology.com
 Paul R. ConklingPrincipal Investigator
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Mary Beth Tombes Ph: 804-628-1357
 Cecelia Boardman, M.D.Principal Investigator
Washington
  Spokane
 Gersh, Robert
 Lorie Mayhle Ph: 509-228-1000
  Email: lorie.mayhle@usoncology.com
 Robert Gersh, M.D.Principal Investigator
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Michelle Jones Ph: 503-525-8642
  Email: michelle.jones@usoncology.com
 David A. SmithPrincipal Investigator
Australia
  Adelaide
 Novartis Investigative Site
  Herston
 Novartis Investigative Site
  Nedlands, WA
 Novartis Investigative Site
  South Brisbane
 Novartis Investigative Site
  St. Leonards, NSW
 Novartis Investigative Site
  Wodonga, VIC
 Novartis Investigative Site
Canada
  Calgary
 Novartis Investigative Site
  Montreal
 Novartis Investigative Site
  North York
 Novartis Investigative Site
  Quebec
 Novartis Investigative Site
  Sherbrooke
 Novartis Investigative Site
  Toronto
 Novartis Investigative Site
  Vancouver
 Novartis Investigative Site
Denmark
  Odence
 Novartis Investigative Site
  Vejle
 Novartis Investigative Site
Finland
  Helinksi
 Novartis Investigative Site
  Kuopio
 Novartis Investigative Site
  Tampere
 Novartis Investigative Site
France
  Amboise
 Novartis Investigative Site
  Bordeaux
 Novartis Investigative Site
  Caen Cedex
 Novartis Investigative Site
  Herblain Cedec
 Novartis Investigative Site
  Villejuif Cedex
 Novartis Investigative Site
Greece
  Athens
 Novartis Investigative Site
Italy
  Bologna
 Novartis Investigative Site
  Milano
 Novartis Investigative Site
  Modena
 Novartis Investigative Site
  Monza
 Novartis Investigative Site
  Padova
 Novartis Investigative Site
  Roma
 Novartis Investigative Site
  Torino
 Novartis Investigative Site
Poland
  Krakow
 Novartis Investigative Site
Republic of South Africa
  Cape Town
 Novartis Investigative Site
  Johannesburg, Gauteng
 Novartis Investigative Site
  Klerksdorp
 Novartis Investigative Site
  Port Elisabeth
 Novartis Investigative Site
  Pretoria, Gauteng
 Novartis Investigative Site
  Pretoria, Guateng
 Novartis Investigative Site
  Sandton, Gauteng
 Novartis Investigative Site
Spain
  Barcelona
 Novartis Investigative Site
  Madrid
 Novartis Investigative Site
United Kingdom
  Glasgow
 Novartis Investigative Site
  London
 Novartis Investigative Site
  Wirral
 Novartis Investigative Site
  Wolverhampton
 Novartis Investigative Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00262990
Information obtained from ClinicalTrials.gov on September 30, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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