TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00102973
First received: February 4, 2005
Last updated: May 30, 2012
Last verified: June 2006
  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 Intervention Phase
Ovarian Neoplasms
Drug: TLK286 in Combination with Carboplatin
Drug: Doxorubicin HCl Liposome Injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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]

Resource links provided by NLM:


Further study details as provided by Telik:

Primary Outcome Measures:
  • Study Objectives [ Time Frame: Every 8 Weeks ] [ Designated as safety issue: Yes ]
    To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin


Enrollment: 244
Study Start Date: December 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLK286 in Combination with Carboplatin Drug: TLK286 in Combination with Carboplatin
Experimental Arm
Active Comparator: Doxorubisin HCl Liposome Injection Drug: Doxorubicin HCl Liposome Injection
Active Comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are a woman 18 years of age or older
  • Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer
  • Have platinum refractory or resistant cancer
  • Measurable disease according to radiographic RECIST criteria with documented tumor progression

Exclusion Criteria:

  • Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)
  • Have clinically significant cardiac disease
  • Have any sign of intestinal obstruction interfering with nutrition at the time of study entry
  • Are pregnant or lactating
  • Had prior treatment with liposomal doxorubicin for ovarian cancer
  • Had prior treatment with TLK286
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102973

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Oncology Associates
Little Rock, Arkansas, United States, 72205
Little Rock Hematology Oncology
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Little Rock Hematology Oncology
Little Rock, Arkansas, United States, 72117
Arkansas Oncology Associates
Little Rock, Arkansas, United States, 72207
United States, California
Southern California Permanente Medical Group
Anaheim, California, United States, 92807
East Bay Oncology/Hematology Medical Associates, Inc.
Antioch, California, United States, 94509
Southern California Permanente Medical Group
Baldwin Park, California, United States, 91706
Southern California Permanente Medical Group
Bellflower, California, United States, 90706
Marilyn Norton, M.D.
Chula Vista, California, United States, 91911
Bay Area Cancer Research Group, LLC
Concord, California, United States, 94520
East Bay Oncology/Hematology Medical Associates, Inc.
Concord, California, United States, 94520
Southwest Cancer Care
Escondido, California, United States, 92025
Southern California Permanente Medical Group
Fontana, California, United States, 92335
California Oncology of the Central Valley
Fresno, California, United States, 93710
Southern California Permanente Medical Group
Harbor City, California, United States, 90710
Kaiser Permanente Medical Center
Hayward, California, United States, 94545
Gynecologic Oncology Associates
La Jolla, California, United States, 92037
Cancer Center Oncology Medical Group
La Mesa, California, United States, 91942
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
LLU Faculty Medical Offices
Loma Linda, California, United States, 92354
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
OB/GYN Consult Suite
Los Angeles, California, United States, 90095
Southern California Permanente Medical Group
Los Angeles, California, United States, 90034
Bowyer Oncology Center
Los Angeles, California, United States, 90095
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Oncology Care Medical Associates
Montebello, California, United States, 90640
Clinical Trials and Research Associates, Inc.
Montebello, California, United States, 90640
Beverly Oncology and Imaging
Montebello, California, United States, 90640
Southwest Cancer Care
Murrieta, California, United States, 92562
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Newport Imaging Center
Newport Beach, California, United States, 92660
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
Kaiser Permanente Medical Center
Oakland, California, United States, 94611
N. County Oncology Medical
Oceanside, California, United States, 92056
Southern California Permanente Medical Group
Panorama City, California, United States, 91402
Southwest Cancer Care
Poway, California, United States, 92064
Southern California Permanente Medical Group
Riverside, California, United States, 92505
Kaiser Permanente Medical Center
Sacramento, California, United States, 95825
Medical Oncology Associates
San Diego, California, United States, 92123
Sharp Rees-Stealy
San Diego, California, United States, 92123
Sharp Memorial Hospital - Investigational Pharmacy
San Diego, California, United States, 92123
Kaiser Permanente Medical Center
San Francisco, California, United States, 94115
Oncology Care Medical Associates
San Gabriel, California, United States, 91776
Kaiser Permanente Medical Center
San Jose, California, United States, 95119
Kaiser Permanente Medical Center
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center
South San Francisco, California, United States, 94080
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center
Walnut Creek, California, United States, 94596
Diablo Valley Oncology & Hematology Medical Group, Inc.
Walnut Creek, California, United States, 94598
Oncology Care Medical Associates
Whittier, California, United States, 90602
Southern Permanente Medical Group
Woodland Hills, California, United States, 91367
United States, Connecticut
University of Connecticut Health Center/John Dempsey Hospital
Farmington, Connecticut, United States, 06030
United States, Florida
The Center for Hematology-Oncology
Boca Raton, Florida, United States, 33486
Citrus Hematology and Oncology Center
Crystal River, Florida, United States, 34428
Citrus Hematology and Oncology Center
Crystal River, Florida, United States, 34429
Citrus Diagnostic Center
Crystal River, Florida, United States, 34428
The Center for Hematology-Oncology
Delray Beach, Florida, United States, 33484
GYN Oncology Associates, Inc.
Hollywood, Florida, United States, 33021
Citrus Memorial Hospital Radiology Dept.
Inverness, Florida, United States, 34452
Citrus Hematology and Oncology Center
Inverness, Florida, United States, 34452
Florida Wellcare Alliance, LC
Inverness, Florida, United States, 34452
Shands Jacksonville Medical Center
Jacksonville, Florida, United States, 32209
Palm Beach Cancer Institute
Jupiter, Florida, United States, 33458
Cancer and Blood Disease Center
Lecanto, Florida, United States, 34461
Florida Hospital
Orlando, Florida, United States, 32803
Gynecology Oncology
Orlando, Florida, United States, 32804
Florida Hospital Memorial System
Ormond Beach, Florida, United States, 32174
Florida Hospital Memorial Division - Cancer Care Center
Ormond Beach, Florida, United States, 32174
Palm Beach Cancer Institute
Palm Beach Gardens, Florida, United States, 33410
GYN Oncology Associates, Inc.
Pembroke Pines, Florida, United States, 33028
Palm Beach Cancer Institute
Wellington, Florida, United States, 33414
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Southeastern Gynecologic Oncology
Atlanta, Georgia, United States, 30342
Southeastern Gynecologic Oncology
Lawrenceville, Georgia, United States, 30045
Southeastern Gynecologic Oncology
Marietta, Georgia, United States, 30060
Southeastern Gynecologic Oncology
Riverdale, Georgia, United States, 30274
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Southeastern Gynecologic Oncology
Tucker, Georgia, United States, 30084
United States, Hawaii
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Illinois
Joliet Oncology-Hematology Associates, Inc.
Flossmoor, Illinois, United States, 60422
Joliet Oncology-Hematology Associates, Inc.
Joliet, Illinois, United States, 60435
Joliet Oncology-Hematology Associates, Inc.
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates, Inc.
Kankakee, Illinois, United States, 60901
Joliet Oncology-Hematology Associates, Inc.
Morris, Illinois, United States, 60450
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46514
St. Vincent Hospital
Indianapolis, Indiana, United States, 46260
LaPorte Hospital
LaPorte, Indiana, United States, 46350
Saint Joseph's Regional Medical Center
South Bend, Indiana, United States, 46617
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Kentucky
University Medical Center, Inc. DBA: U of L Hospital
Louisville, Kentucky, United States, 40202
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology and Oncology Specialists, LLC
Covington, Louisiana, United States, 70433
OncRx (Pharmacy)
Metairie, Louisiana, United States, 70002
Hematology and Oncology Specialist
New Orleans, Louisiana, United States, 70006
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Maine Medical Center - Brighton Campus
Portland, Maine, United States, 04102
Maine Medical Center - Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Center for Cancer and Blood Disorders, P. C.
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber/Partners Cancer Care, Inc.
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Boston Medical Center - Center for Cancer and Blood Disorders
Boston, Massachusetts, United States, 02118
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Perceptive Informatics, Inc.
Waltham, Massachusetts, United States, 02451
United States, Michigan
Sparrow Health System
Lansing, Michigan, United States, 48912
Lakeland Hospital
Niles, Michigan, United States, 49120
Providence Cancer Institute and Hospital
Southfield, Michigan, United States, 48075
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Duluth Clinic
Duluth, Minnesota, United States, 55805
United States, Mississippi
The Family Cancer Center
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
St. John's Mercy-David C. Pratt Cancer Center
St. Louis, Missouri, United States, 63141
Saint Louis University
St. Louis, Missouri, United States, 63117
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Montana
Deaconess Billings Clinic
Billings, Montana, United States, 59101
United States, Nebraska
Hematology & Oncology Consultants, PC
Omaha, Nebraska, United States, 68122
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Horizons West Medical Group
Scottsbluff, Nebraska, United States, 69361
The Women's Center of Western Nebraska
Scottsbluff, Nebraska, United States, 69361
Odyssey Research
Scottsbluff, Nebraska, United States, 69361
Regional West Medical Center
Scottsbluff, Nebraska, United States, 69361
United States, New Hampshire
Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
A. Richard Miskoff, DO, PA
Edison, New Jersey, United States, 08818
JFK Medical Center
Edison, New Jersey, United States, 08818
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Jsumc Ob/Gyn
West Long Branch, New Jersey, United States, 07764
United States, New York
Gynecologic Oncology & Minimally Invasive Surgery
Babylon, New York, United States, 11702
The Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Schwartz Gynecologic Oncology
East Islip, New York, United States, 11730
North Shore University Hospital
Manhasset, New York, United States, 11030
Hematology-Oncology Associates of Rockland
New City, New York, United States, 10956
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
The Union State Bank Cancer Center
Nyack, New York, United States, 10960
United States, North Carolina
Asheville Radiology
Asheville, North Carolina, United States, 28801
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28816
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7570
Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28204
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Presbyterian Gynecologic Oncology
Charlotte, North Carolina, United States, 28204
Inpatient Pharmacy
Charlotte, North Carolina, United States, 28203
Piedmont Hematology Oncology Associates
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Cancer Care Center - Medcenter One, Inc.
Bismarck, North Dakota, United States, 58501
Odyssey Research
Bismarck, North Dakota, United States, 58501
Cancer Treatment & Research Center - Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States, 58501
Dakota Cancer Institute
Fargo, North Dakota, United States, 58103
Odyssey Research
Fargo, North Dakota, United States, 58104
United States, Ohio
UC Physician's Medical Arts Building
Cincinnati, Ohio, United States, 45219
Barrett Cancer Center
Cincinnati, Ohio, United States, 45219-0501
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Fairview Hospital Moll Pavilion
Cleveland, Ohio, United States, 44111
Mid Ohio Onc/Hem (East)
Columbus, Ohio, United States, 43213
Mid Ohio Onc/Hem (West)
Columbus, Ohio, United States, 43222
GOPSA
Columbus, Ohio, United States, 43222
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Hillcrest Hospital/Cleveland Clinic Health System
Mayfield Heights, Ohio, United States, 44124
The Toledo Hospital
Toledo, Ohio, United States, 43606
ProMedica Health System
Toledo, Ohio, United States, 43606
Garth Phibbs, M.D., FACOG
Toledo, Ohio, United States, 43606
Mid Onio Onc/Hem (North)
Westerville, Ohio, United States, 43081
United States, Oklahoma
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
Cancer Care Associates
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Kaiser Permanente Northwest Region
Portland, Oregon, United States, 97227
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Advance Imaging
Dunmore, Pennsylvania, United States, 18512
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania, United States, 18512
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Community Medical Center
Scranton, Pennsylvania, United States, 18510
Mercy Health Partners
Scranton, Pennsylvania, United States, 18510
Hematology & Oncology Associates of NEPA
Scranton, Pennsylvania, United States, 18508
Moses Taylor Hospital
Scranton, Pennsylvania, United States, 18510
Viewmont Medical Services
Scranton, Pennsylvania, United States, 18508
Associates in Hematology-Oncology, P.C.
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Roper Hospital-Department of Radiology
Charleston, South Carolina, United States, 29401
Carolina Center of Gynecologic Oncology, PA
Charleston, South Carolina, United States, 29407
South Carolina Oncology
Columbia, South Carolina, United States, 29210
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sioux Valley Clinic Oncology
Sioux Falls, South Dakota, United States, 57104
Sioux Valley Clinic - Clinical Research Center
Sioux Falls, South Dakota, United States, 57104
Sioux Valley Clinic OBGYN, Ltd.
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital - North Center Radiology
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
The Family Cancer Center
Bartlett, Tennessee, United States, 38133
Parkridge Medical Center
Chattanooga, Tennessee, United States, 37404
Baroness Erlander Hospital
Chattanooga, Tennessee, United States, 37403
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States, 37403
The Family Cancer Center
Collierville, Tennessee, United States, 38017
The Family Cancer Center
Memphis, Tennessee, United States, 38119
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Texas Cancer Associates
Dallas, Texas, United States, 75231
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States, 75230
Texas Cancer Associates
Plano, Texas, United States, 75093
Center for Oncology Research and Treatment, PA
Richardson, Texas, United States, 75080
United States, Virginia
Danville Hematology and Oncology, Inc.
Danville, Virginia, United States, 24541
VCU Health System-Dalton Oncology Clinic, North Hospital
Richmond, Virginia, United States, 23298
VCU Health System at Stony Point
Richmond, Virginia, United States, 23235
Carilion GYN Oncology Associates
Roanoke, Virginia, United States, 24014
United States, Washington
Western Washington Oncology, Inc., P.S.
Aberdeen, Washington, United States, 98520
Western Washington Oncology, Inc., P. S.
Centralia, Washington, United States, 98531
Covington MultiCare - Oncology Clinic
Covington, Washington, United States, 98042-4951
Gig Harbor Medical Oncology
Gig Harbor, Washington, United States, 98335
Western Washington Oncology, Inc., P.S.
Lacey, Washington, United States, 98503
Western Washington Oncology, Inc., P.S.
Shelton, Washington, United States, 98584
MultiCare Health System - Medical Oncology
Tacoma, Washington, United States, 98405
Allenmore Hospital - Hematology Oncology Clinic
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield Clinic - Chippewa Falls Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
St. Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Marchfield Clinic - Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Telik
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00102973     History of Changes
Other Study ID Numbers: TLK286.3024
Study First Received: February 4, 2005
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
Ovary

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013