Clinical Trial: TLK286 (Telcyta) in Combination w/Carboplatin (Paraplatin) vs. Doxil in Platinum Refractory or Resistant Ovarian Cancer

This study is currently recruiting patients.

Sponsored by: Telik
Information provided by: Telik

Purpose

The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.

Condition Treatment or Intervention Phase
Ovarian Neoplasms
 Drug: TLK286 (Telcyta) HCI for Injection
 Drug: Carboplatin, Paraplatin for Injection
 Drug: Doxorubicin HCI Liposome Injection
Phase III

MedlinePlus related topics:  Ovarian Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Phase III Randomized Study of TLK286 (Telcyta) in Combination with Carboplatin (Paraplatin) versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

Further Study Details: 

Expected Total Enrollment:  244

Study start: December 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information


Arkansas
      Little Rock Hematology Oncology, Little Rock,  Arkansas,  72205,  United States; Recruiting
Priscilla Gray  501-907-6177  Ext. 421    pgray@lrho.org 
Brad P. Baltz, MD,  Principal Investigator

      Little Rock Hematology Oncology Benton, Benton,  Arkansas,  72015,  United States; Recruiting
Priscilla Gray  501-907-6177    pgray@lrho.org 
Brad Baltz, MD,  Principal Investigator

California
      Gynecologic Oncology Associates, Newport Beach,  California,  92663,  United States; Recruiting
Cheri Graham, RN  949-642-5165    research@gynoncology.com 
John P. Micha, MD,  Principal Investigator

      Newport Imaging Center, Newport Beach,  California,  92660,  United States; Recruiting
Cheri Graham, RN  949-642-5165    research@gynoncology.com 
John P. Micha, MD,  Principal Investigator

      Hoag Memorial Hospital Presbyterian, Newport Beach,  California,  92663,  United States; Recruiting
Cheri Graham, RN  949-642-5165    research@gynoncology.com 
John P. Micha, MD,  Principal Investigator

      Southwest Cancer Care, Poway,  California,  92064,  United States; Recruiting
Karie Fortin  858-451-7066    swccresearch@aol.com 
Michael A. Kosmo, MD,  Principal Investigator

      Southwest Cancer Care, Escondido,  California,  92025,  United States; Recruiting
Karie Fortin  858-451-7066    swccresearch@aol.com 
Michael A. Kosmo, MD,  Principal Investigator

      Southwest Cancer Care, Murrieta,  California,  92562,  United States; Recruiting
Karie Fortin  858-451-7066    swccresearch@aol.com 
Michael A. Kosmo, MD,  Principal Investigator

      Bay Area Cancer Research Group, LLC, Concord,  California,  94520,  United States; Recruiting
Adriane Rubit  925-676-4740  Ext. 101    arubit@bacrg.com 
Ostap G. Melnyk, MD,  Principal Investigator

      Diablo Valley Oncology & Hematology Medical Group, Inc., Walnut Creek,  California,  94598,  United States; Recruiting
Adriane Rubit  925-676-4740  Ext. 101    arubit@bacrg.com 
Ostap G. Melnyk, MD,  Principal Investigator

      East Bay Oncology/Hematology Medical Associates, Inc., Concord,  California,  94520,  United States; Recruiting
Adriane Rubit  925-676-4740  Ext. 101    arubit@bacrg.com 
Ostap G. Melnyk, MD,  Principal Investigator

      East Bay Oncology/Hematology Medical Associates, Inc., Antioch,  California,  94509,  United States; Recruiting
Adriane Rubit  925-676-4740  Ext. 101    arubit@bacrg.com 
Ostap G. Melnyk, MD,  Principal Investigator

      Gynecologic Oncology Associates, La Jolla,  California,  92037,  United States; Recruiting
Dawn Noakes  858-455-5524    dawn@gynoncology.com 
Bridgette Duggan, MD,  Principal Investigator

      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
Lisa Michelsen, CCRP  909-558-3375    lmichelsen@ahs.llumc.edu 
Hyun S. Shvartsman, MD,  Principal Investigator

      LLU Faculty Medical Offices, Loma Linda,  California,  92354,  United States; Recruiting
Lisa Michelsen, CCRP  909-558-3375    lmichelsen@ahs.llumc.edu 
Hyun S. Shvartsman, MD,  Principal Investigator

Florida
      Shands Jacksonville Medical Center, Jacksonville,  Florida,  32209,  United States; Recruiting
B. Lynn Musselman  904-633-0064    lynn.musselman@jax.ufl.edu 
Rita Carsten  904-244-3854    rita.carsten@jax.ufl.edu 
Guy I. Benrubi, MD,  Principal Investigator

      GYN Oncology Associates, Inc., Pembroke Pines,  Florida,  33028,  United States; Recruiting
Deena Bernstein  954-838-2729    dbernstein@shcr.com 
Ely Brand, MD,  Principal Investigator

      GYN Oncology Associates, Inc., Hollywood,  Florida,  33021,  United States; Recruiting
Deena Bernstein  954-838-2729    dbernstein@shcr.com 
Ely Brand, MD,  Principal Investigator

      Palm Beach Cancer Institute, West Palm Beach,  Florida,  33401,  United States; Recruiting
Tammy Fraga  561-366-4128    tammy.fraga@pbcancer.com 
Daniel Spitz, MD,  Principal Investigator

      Palm Beach Cancer Institute, Palm Beach Gardens,  Florida,  33410,  United States; Recruiting
Tammy Fraga  561-366-4128    tammy.fraga@pbcancer.com 
Daniel Spitz, MD,  Principal Investigator

      Palm Beach Cancer Institute, Wellington,  Florida,  33414,  United States; Recruiting
Tammy Fraga  561-366-4128    tammy.fraga@pbcancer.com 
Daniel Spitz, MD,  Principal Investigator

Hawaii
      Kapiolani Medical Center for Women and Children, Honolulu,  Hawaii,  96826,  United States; Recruiting
Mary Kessel  808-983-6290    MaryK@kapiolani.org 
Suzanne Ditter  808-983-6094    suzanned@kapiolani.org 
Michael Carney, MD,  Principal Investigator

Illinois
      Hematology Oncology Associates of Illinois (HOAI), Skokie,  Illinois,  60076,  United States; Recruiting
Sharon Goldman  847-673-1999    sgoldman@cancerstudy.com 
Ira A. Oliff, MD,  Principal Investigator

      Midwest Cancer Research Group, Inc., Skokie,  Illinois,  60076,  United States; Recruiting
Sharon Goldman  847-673-1999    sgoldman@cancerstudy.com 
Ira A. Oliff, MD,  Principal Investigator

      Deerpath Medical Associates, Lake Forest,  Illinois,  60045,  United States; Recruiting
Sharon Goldman  847-673-1999    sgoldman@cancerstudy.com 
Ira A. Oliff, MD,  Principal Investigator

      North Shore Oncology Hematology Associates, Barrington,  Illinois,  60010,  United States; Recruiting
Sharon Goldman  847-673-1999    sgoldman@cancerstudy.com 
Ira A. Oliff, MD,  Principal Investigator

      North Shore Oncology Hematology Associates, Libertyville,  Illinois,  60048,  United States; Recruiting
Sharon Goldman  847-673-1999    sgoldman@cancerstudy.com 
Ira A. Oliff, MD,  Principal Investigator

      Sage Cancer Center, McHenry,  Illinois,  60050,  United States; Recruiting
Sharon Goldman  847-673-1999    sgoldman@cancerstudy.com 
Ira A. Oliff, MD,  Principal Investigator

      Swedish Covenant Cancer Center, Chicago,  Illinois,  60625,  United States; Recruiting
Sharon Goldman  847-673-1999    sgoldman@cancerstudy.com 

Louisiana
      Hematology and Oncology Specialist, New Orleans,  Louisiana,  70115,  United States; Recruiting
Mary Ann Ostroske  504-894-7115  Ext. 221    mostroske1@salco.net 
Patricia Braly, MD,  Principal Investigator

      Hematology and Oncology Specialists, LLC, Covington,  Louisiana,  70433,  United States; Recruiting
Mary Ann Ostroske  504-894-7115  Ext. 221    mostroske1@salco.net 
Patricia S. Braly, MD,  Principal Investigator

      OncRx (Pharmacy), Metairie,  Louisiana,  70002,  United States; Recruiting
Mary Ann Ostroske  504-894-7115  Ext. 221    mostroske1@salco.net 
Patricia S. Braly, MD,  Principal Investigator

Maryland
      Center for Cancer and Blood Disorders, P. C., Bethesda,  Maryland,  20817,  United States; Recruiting
Natalie Bongiorno, RN  301-571-0019  Ext. 121    nbongiorno@ccbdmd.com 
Ralph V. Boccia, MD,  Principal Investigator

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Alison Mallett  617-726-1227    amallett@partners.org 
Carolyn Krasner, MD,  Principal Investigator

      Dana Farber/Partners Cancer Care, Inc., Boston,  Massachusetts,  02115,  United States; Recruiting
Tina Atkinson  617-632-2621    tina_atkinson@dfci.harvard.edu 
Carolyn Krasner, MD,  Principal Investigator

      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Laurel Bisano  617-667-5987    lbisano@bidmc.harvard.edu 
Carolyn Krasner, MD,  Principal Investigator

Michigan
      Sparrow Health System, Lansing,  Michigan,  48912,  United States; Recruiting
Wendy Walker, RN  517-364-2921    wendy-walker@sparrow.org 
Joseph Meunier, DO,  Principal Investigator

Missouri
      St. John's Mercy Medical Center, St. Louis,  Missouri,  63141,  United States; Recruiting
Amy Siesennop, RN  314-251-7059    siesaj@stlo.mercy.com 
Kevin O. Easley, JD, MD,  Principal Investigator

      St. John's Mercy-David C. Pratt Cancer Center, St. Louis,  Missouri,  63141,  United States; Recruiting
Amy Siesennop, RN  314-251-7059    siesaj@stlo.mercy.com 
Kevin O. Easley, JD, MD,  Principal Investigator

Nebraska
      Horizons West Medical Group, Scottsbluff,  Nebraska,  69361,  United States; Recruiting
Kim Magana  308-632-2899    kmagana@odysseyresearch.org 
Sherry Jennings  843-556-4380 
Vincent G. Bjorling, MD,  Principal Investigator

      Odyssey Research, Scottsbluff,  Nebraska,  69361,  United States; Recruiting
Kim Magana  308-632-2899    kmagan@odysseyresearch.org 
Sherry Jennings  843-556-4380 
Vincent G. Bjorling, MD,  Principal Investigator

      Regional West Medical Center, Scottsbluff,  Nebraska,  69361,  United States; Recruiting
Kim Magana  308-632-2899    kmagana@odysseyresearch.org 
Sherry Jennings  843-556-4380 
Vincent G. Bjorling, MD,  Principal Investigator

      The Women's Center of Western Nebraska, Scottsbluff,  Nebraska,  69361,  United States; Recruiting
Kim Magana  308-632-2899    kmagana@odysseyresearch.org 
Sherry Jennings  843-556-4380 
Vincent G. Bjorling, MD,  Principal Investigator

New York
      Gynecologic Oncology & Minimally Invasive Surgery, Babylon,  New York,  11702,  United States; Recruiting
Andrea Ancell Barros  631-334-2030    aa@schwartzoncology.com 
Benjamin Schwartz, MD,  Principal Investigator

North Dakota
      Cancer Care Center - Medcenter One, Inc., Bismarck,  North Dakota,  58501,  United States; Recruiting
Laurie Holverson  701-250-8416    lholverson@odysseyresearch.org 
Seymour M. Bronstein, MD,  Principal Investigator

      Odyssey Research, Bismarck,  North Dakota,  58501,  United States; Recruiting
Laurie Holverson  701-250-8416    lholverson@odysseyresearch.org 
Seymour M. Bronstein, MD,  Principal Investigator

      Cancer Treatment & Research Center - Mid Dakota Clinic, P. C., Bismarck,  North Dakota,  58501,  United States; Recruiting
Shari Sanders  701-250-8420    ssanders@odysseyresearch.org 
M. (Mathew) Roy Thomas, MD,  Principal Investigator

      Odyssey Research, Bismarck,  North Dakota,  58501,  United States; Recruiting
Shari Sanders  701-250-8420    ssanders@odysseyresearch.org 
M. (Mathew) Roy Thomas, MD,  Principal Investigator

      Dakota Cancer Institute, Fargo,  North Dakota,  58103,  United States; Recruiting
Kathy Wamsley  701-250-1355    kwamsley@odysseyresearch.org 
Kaushik Sen, MD,  Principal Investigator

      Odyssey Research, Fargo,  North Dakota,  58104,  United States; Recruiting
Kathy Wamsley  701-250-7355    kwamsley@odysseyresearch.org 
Kaushik Sen, MD,  Principal Investigator

Pennsylvania
      Hematology & Oncology Associates of NEPA, Dunmore,  Pennsylvania,  18512,  United States; Recruiting
LeeAnn Haefele, RN  570-342-3675  Ext. 218    l.haefele@hemonl.com 
William J. Heim, MD,  Principal Investigator

      Hematology & Oncology Associates of NEPA, Scranton,  Pennsylvania,  18508,  United States; Recruiting
LeeAnn Haefele, RN  570-342-3675  Ext. 218    l.haefele@hemonl.com 
William J. Heim, MD,  Principal Investigator

      Mercy Health Partners, Scranton,  Pennsylvania,  18510,  United States; Recruiting
LeeAnn Haefele  570-342-3675  Ext. 218    l.haefele@hemonl.com 
William J. Heim, MD,  Principal Investigator

      Moses Taylor Hospital, Scranton,  Pennsylvania,  18510,  United States; Recruiting
LeeAnn Haefele, RN  570-342-3675  Ext. 218    l.haefele@hemonl.com 
William J. Heim, MD,  Principal Investigator

      Community Medical Center, Scranton,  Pennsylvania,  18510,  United States; Recruiting
LeeAnn Haefele, RN  570-342-3675  Ext. 218    l.haefele@hemonl.com 
William J. Heim, MD,  Principal Investigator

      Viewmont Medical Services, Scranton,  Pennsylvania,  18508,  United States; Recruiting
LeeAnn Haefele, RN  570-342-3675  Ext. 218    l.haefele@hemonl.com 
William J. Heim, MD,  Principal Investigator

      Advance Imaging, Dunmore,  Pennsylvania,  18512,  United States; Recruiting
LeeAnn Haefele, RN  570-342-3675  Ext. 218    l.haefele@hemonl.com 
William J. Heim, MD,  Principal Investigator

South Carolina
      South Carolina Oncology, Columbia,  South Carolina,  29210,  United States; Recruiting
Debby Green  803-461-3096    dgreen@sconcology.net 
James A. Williams, Jr., MD,  Principal Investigator

Texas
      Arlington Cancer Center, Arlington,  Texas,  76012,  United States; Recruiting
Laura Rice  817-261-0929  Ext. 1443    lrice@acc-tx.com 
Barry Firstenberg, DO,  Principal Investigator

      Texas Cancer Associates, Dallas,  Texas,  75231,  United States; Recruiting
Robbin Paul  214-739-1706    rrpaul@txcan.com 
Susan C. Guba, MD,  Principal Investigator

      Texas Cancer Associates, Plano,  Texas,  75093,  United States; Recruiting
Robbin Paul  214-739-1706    rrpaul@txcan.com 
Susan C. Guba, MD,  Principal Investigator

Washington
      Western Washington Oncology, Inc., P.S., Lacey,  Washington,  98503,  United States; Recruiting
Kim Courtney  306-412-8919    kim@wwctc.com 
Dustan C. Osborn, MD,  Principal Investigator

      Western Washington Oncology, Inc., P.S., Aberdeen,  Washington,  98520,  United States; Recruiting
Kim Courtney  306-412-8919    kim@wwctc.com 
Dustan C. Osborn, MD,  Principal Investigator

      Western Washington Oncology, Inc., P.S., Shelton,  Washington,  98584,  United States; Recruiting
Kim Courtney  306-412-8919    kim@wwctc.com 
Dustan C. Osborn, MD,  Principal Investigator

      Western Washington Oncology, Inc., P. S., Centralia,  Washington,  98531,  United States; Recruiting
Kim Courtney  306-412-8919    kim@wwctc.com 
Dustan C. Osborn, MD,  Principal Investigator

      MultiCare Health System - Medical Oncology, Tacoma,  Washington,  98405,  United States; Recruiting
Richard Shine  253-403-7250    richard.shine@multicare.org 
David E. Young, MD,  Principal Investigator

      Allenmore Hospital - Hematology Oncology Clinic, Tacoma,  Washington,  98405,  United States; Recruiting
Richard Shine  253-403-7250    richard.shine@multicare.org 
David E. Young, MD,  Principal Investigator

      Covington MultiCare - Oncology Clinic, Covington,  Washington,  98042-4951,  United States; Recruiting
Richard Shine  253-403-7250    richard.shine@multicare.org 
David E. Young, MD,  Principal Investigator

Wisconsin
      Marshfield Clinic, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD, PhD,  Principal Investigator

      Marshfield Clinic - Chippewa Falls Center, Chippewa Falls,  Wisconsin,  54729,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD, PhD,  Principal Investigator

      Marshfield Clinic - Indianhead Center, Rice Lake,  Wisconsin,  54868,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD, PhD,  Principal Investigator

      Marshfield Clinic - Lakeland Center, Minocqua,  Wisconsin,  54548,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD, PhD,  Principal Investigator

      Marchfield Clinic - Wausau Center, Wausau,  Wisconsin,  54401,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD, PhD,  Principal Investigator

      Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids,  Wisconsin,  54494,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD, PhD,  Principal Investigator

      Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital, Eau Claire,  Wisconsin,  54701,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD,PhD,  Principal Investigator

      St. Michael's Hospital, Stevens Point,  Wisconsin,  54481,  United States; Recruiting
Donna Hoover, CRC  715-389-5592    hoover.donna@mcrf.mfldclin.edu 
Anthony C. Evans, Jr., MD, PhD,  Principal Investigator

More Information

Study ID Numbers:  TLK286.3024
Record last reviewed:  March 2005
Last Updated:  March 29, 2005
Record first received:  February 4, 2005
ClinicalTrials.gov Identifier:  NCT00102973
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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