CClinicalTrials.gg
CompletedNCT00102973Updated May 31, 2012

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

A Phase 3 interventional study of TLK286 in Combination with Carboplatin and Doxorubicin HCl Liposome Injection in Ovarian Neoplasms, sponsored by Telik. Completed at 222 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-31.

Sponsored by Telik · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
244
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

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Conditions studied

  • Ovarian Neoplasms

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Keywords

  • Ovary
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 244 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Telik is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
244 participants (actual)

Study arms

  • Experimental
    TLK286 in Combination with Carboplatin

    Drug: TLK286 in Combination with Carboplatin

  • Active comparator
    Doxorubisin HCl Liposome Injection

    Drug: Doxorubicin HCl Liposome Injection

Interventions

  • DrugTLK286 in Combination with Carboplatin

    Experimental Arm

  • DrugDoxorubicin HCl Liposome Injection

    Active Comparator

06

What researchers measure

Primary outcomes

  1. Study Objectives

    To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin

    Time frame: Every 8 Weeks

07

Study locations

222 sites
  • Little Rock Hematology Oncology
    Little Rock, Arkansas 72117, United States
  • Arkansas Oncology Associates
    Little Rock, Arkansas 72205, United States
  • Little Rock Hematology Oncology
    Little Rock, Arkansas 72205, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Arkansas Oncology Associates
    Little Rock, Arkansas 72207, United States
  • Southern California Permanente Medical Group
    Anaheim, California 92807, United States
  • East Bay Oncology/Hematology Medical Associates, Inc.
    Antioch, California 94509, United States
  • Southern California Permanente Medical Group
    Baldwin Park, California 91706, United States
  • Southern California Permanente Medical Group
    Bellflower, California 90706, United States
  • Marilyn Norton, M.D.
    Chula Vista, California 91911, United States
  • Bay Area Cancer Research Group, LLC
    Concord, California 94520, United States
  • East Bay Oncology/Hematology Medical Associates, Inc.
    Concord, California 94520, United States
  • Southwest Cancer Care
    Escondido, California 92025, United States
  • Southern California Permanente Medical Group
    Fontana, California 92335, United States
  • California Oncology of the Central Valley
    Fresno, California 93710, United States
  • Southern California Permanente Medical Group
    Harbor City, California 90710, United States
  • Kaiser Permanente Medical Center
    Hayward, California 94545, United States
  • Gynecologic Oncology Associates
    La Jolla, California 92037, United States
  • Cancer Center Oncology Medical Group
    La Mesa, California 91942, United States
  • LLU Faculty Medical Offices
    Loma Linda, California 92354, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Southern California Permanente Medical Group
    Los Angeles, California 90027, United States
  • Southern California Permanente Medical Group
    Los Angeles, California 90034, United States
  • Bowyer Oncology Center
    Los Angeles, California 90095, United States
  • David Geffen School of Medicine at UCLA
    Los Angeles, California 90095, United States
  • OB/GYN Consult Suite
    Los Angeles, California 90095, United States
  • Beverly Oncology and Imaging
    Montebello, California 90640, United States
  • Clinical Trials and Research Associates, Inc.
    Montebello, California 90640, United States
  • Oncology Care Medical Associates
    Montebello, California 90640, United States
  • Southwest Cancer Care
    Murrieta, California 92562, United States
  • Newport Imaging Center
    Newport Beach, California 92660, United States
  • Gynecologic Oncology Associates
    Newport Beach, California 92663, United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92663, United States
  • Kaiser Permanente Medical Center
    Oakland, California 94611, United States
  • N. County Oncology Medical
    Oceanside, California 92056, United States
  • Southern California Permanente Medical Group
    Panorama City, California 91402, United States
  • Southwest Cancer Care
    Poway, California 92064, United States
  • Southern California Permanente Medical Group
    Riverside, California 92505, United States
  • Kaiser Permanente Medical Center
    Sacramento, California 95825, United States
  • Medical Oncology Associates
    San Diego, California 92123, United States
  • Sharp Memorial Hospital - Investigational Pharmacy
    San Diego, California 92123, United States
  • Sharp Rees-Stealy
    San Diego, California 92123, United States
  • Kaiser Permanente Medical Center
    San Francisco, California 94115, United States
  • Oncology Care Medical Associates
    San Gabriel, California 91776, United States
  • Kaiser Permanente Medical Center
    San Jose, California 95119, United States
  • Kaiser Permanente Medical Center
    Santa Clara, California 95051, United States
  • Kaiser Permanente Medical Center
    South San Francisco, California 94080, United States
  • Kaiser Permanente Medical Center
    Vallejo, California 94589, United States
  • Kaiser Permanente Medical Center
    Walnut Creek, California 94596, United States
  • Diablo Valley Oncology & Hematology Medical Group, Inc.
    Walnut Creek, California 94598, United States
  • Oncology Care Medical Associates
    Whittier, California 90602, United States
  • Southern Permanente Medical Group
    Woodland Hills, California 91367, United States
  • University of Connecticut Health Center/John Dempsey Hospital
    Farmington, Connecticut 06030, United States
  • The Center for Hematology-Oncology
    Boca Raton, Florida 33486, United States
  • Citrus Diagnostic Center
    Crystal River, Florida 34428, United States
  • Citrus Hematology and Oncology Center
    Crystal River, Florida 34428, United States
  • Citrus Hematology and Oncology Center
    Crystal River, Florida 34429, United States
  • The Center for Hematology-Oncology
    Delray Beach, Florida 33484, United States
  • GYN Oncology Associates, Inc.
    Hollywood, Florida 33021, United States
  • Citrus Hematology and Oncology Center
    Inverness, Florida 34452, United States
  • Citrus Memorial Hospital Radiology Dept.
    Inverness, Florida 34452, United States
  • Florida Wellcare Alliance, LC
    Inverness, Florida 34452, United States
  • Shands Jacksonville Medical Center
    Jacksonville, Florida 32209, United States
  • Palm Beach Cancer Institute
    Jupiter, Florida 33458, United States
  • Cancer and Blood Disease Center
    Lecanto, Florida 34461, United States
  • Florida Hospital
    Orlando, Florida 32803, United States
  • Gynecology Oncology
    Orlando, Florida 32804, United States
  • Florida Hospital Memorial Division - Cancer Care Center
    Ormond Beach, Florida 32174, United States
  • Florida Hospital Memorial System
    Ormond Beach, Florida 32174, United States
  • Palm Beach Cancer Institute
    Palm Beach Gardens, Florida 33410, United States
  • GYN Oncology Associates, Inc.
    Pembroke Pines, Florida 33028, United States
  • Palm Beach Cancer Institute
    Wellington, Florida 33414, United States
  • Palm Beach Cancer Institute
    West Palm Beach, Florida 33401, United States
  • Southeastern Gynecologic Oncology
    Atlanta, Georgia 30342, United States
  • Southeastern Gynecologic Oncology
    Lawrenceville, Georgia 30045, United States
  • Southeastern Gynecologic Oncology
    Marietta, Georgia 30060, United States
  • Southeastern Gynecologic Oncology
    Riverdale, Georgia 30274, United States
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
  • Southeastern Gynecologic Oncology
    Tucker, Georgia 30084, United States
  • Kaiser Permanente Hawaii
    Honolulu, Hawaii 96819, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Joliet Oncology-Hematology Associates, Inc.
    Flossmoor, Illinois 60422, United States
  • Joliet Oncology-Hematology Associates, Inc.
    Joliet, Illinois 60432, United States
  • Joliet Oncology-Hematology Associates, Inc.
    Joliet, Illinois 60435, United States
  • Joliet Oncology-Hematology Associates, Inc.
    Kankakee, Illinois 60901, United States
  • Joliet Oncology-Hematology Associates, Inc.
    Morris, Illinois 60450, United States
  • Elkhart General Hospital
    Elkhart, Indiana 46514, United States
  • St. Vincent Hospital
    Indianapolis, Indiana 46260, United States
  • LaPorte Hospital
    LaPorte, Indiana 46350, United States
  • Memorial Hospital of South Bend
    South Bend, Indiana 46601, United States
  • Saint Joseph's Regional Medical Center
    South Bend, Indiana 46617, United States
  • James Graham Brown Cancer Center
    Louisville, Kentucky 40202, United States
  • University Medical Center, Inc. DBA: U of L Hospital
    Louisville, Kentucky 40202, United States
  • Hematology and Oncology Specialists, LLC
    Covington, Louisiana 70433, United States
  • OncRx (Pharmacy)
    Metairie, Louisiana 70002, United States
  • Hematology and Oncology Specialist
    New Orleans, Louisiana 70006, United States
  • LSU Health Sciences Center
    Shreveport, Louisiana 71103, United States
  • Maine Medical Center - Brighton Campus
    Portland, Maine 04102, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • Maine Medical Center - Scarborough Campus
    Scarborough, Maine 04074, United States

Showing the first 100 of 222 sites.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00102973
Lead sponsor
Telik
Responsible party
Sponsor
First posted
Feb 7, 2005
Start date
Dec 2004
Primary completion
Jul 2008
Completion
Jul 2008
Last update
May 31, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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