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Ovarian NeoplasmsPhase 3NCT00102973

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

A Phase 3 study testing TLK286 in Combination with Carboplatin and Doxorubicin HCl Liposome Injection in people with Ovarian Neoplasms, run by Telik at 222 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
TLK286 in Combination with Carboplatin and Doxorubicin HCl Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
222 sitesUnited States
Study dates
Dec 2004to Jul 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

222 sites in 1 country.

222 sites in 1 country

United States222 sites

  • Western Washington Oncology, Inc., P.S.

    Aberdeen, Washington, 98520

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Southern California Permanente Medical Group

    Anaheim, California, 92807

  • East Bay Oncology/Hematology Medical Associates, Inc.

    Antioch, California, 94509

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Asheville Radiology

    Asheville, North Carolina, 28801

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28816

  • Southeastern Gynecologic Oncology

    Atlanta, Georgia, 30342

  • Gynecologic Oncology & Minimally Invasive Surgery

    Babylon, New York, 11702

  • Southern California Permanente Medical Group

    Baldwin Park, California, 91706

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • The Family Cancer Center

    Bartlett, Tennessee, 38133

  • Southern California Permanente Medical Group

    Bellflower, California, 90706

  • Center for Cancer and Blood Disorders, P. C.

    Bethesda, Maryland, 20817

  • Deaconess Billings Clinic

    Billings, Montana, 59101

  • Cancer Care Center - Medcenter One, Inc.

    Bismarck, North Dakota, 58501

  • Cancer Treatment & Research Center - Mid Dakota Clinic, P. C.

    Bismarck, North Dakota, 58501

  • Odyssey Research

    Bismarck, North Dakota, 58501

  • The Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber/Partners Cancer Care, Inc.

    Boston, Massachusetts, 02115

  • Boston Medical Center - Center for Cancer and Blood Disorders

    Boston, Massachusetts, 02118

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Western Washington Oncology, Inc., P. S.

    Centralia, Washington, 98531

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7570

  • Roper Hospital-Department of Radiology

    Charleston, South Carolina, 29401

  • Carolina Center of Gynecologic Oncology, PA

    Charleston, South Carolina, 29407

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Inpatient Pharmacy

    Charlotte, North Carolina, 28203

  • Blumenthal Cancer Center

    Charlotte, North Carolina, 28204

  • Presbyterian Gynecologic Oncology

    Charlotte, North Carolina, 28204

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Baroness Erlander Hospital

    Chattanooga, Tennessee, 37403

  • Chattanooga GYN Oncology

    Chattanooga, Tennessee, 37403

  • Parkridge Medical Center

    Chattanooga, Tennessee, 37404

  • Marshfield Clinic - Chippewa Falls Center

    Chippewa Falls, Wisconsin, 54729

  • Marilyn Norton, M.D.

    Chula Vista, California, 91911

  • Barrett Cancer Center

    Cincinnati, Ohio, 45219-0501

  • UC Physician's Medical Arts Building

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Fairview Hospital Moll Pavilion

    Cleveland, Ohio, 44111

  • The Family Cancer Center

    Collierville, Tennessee, 38017

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • South Carolina Oncology

    Columbia, South Carolina, 29210

  • Mid Ohio Onc/Hem (East)

    Columbus, Ohio, 43213

  • GOPSA

    Columbus, Ohio, 43222

  • Mid Ohio Onc/Hem (West)

    Columbus, Ohio, 43222

  • Bay Area Cancer Research Group, LLC

    Concord, California, 94520

  • East Bay Oncology/Hematology Medical Associates, Inc.

    Concord, California, 94520

  • The Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Hematology and Oncology Specialists, LLC

    Covington, Louisiana, 70433

  • Covington MultiCare - Oncology Clinic

    Covington, Washington, 98042-4951

  • Citrus Diagnostic Center

    Crystal River, Florida, 34428

  • Citrus Hematology and Oncology Center

    Crystal River, Florida, 34428

  • Citrus Hematology and Oncology Center

    Crystal River, Florida, 34429

  • Center for Oncology Research and Treatment, PA

    Dallas, Texas, 75230

  • Texas Cancer Associates

    Dallas, Texas, 75231

  • Danville Hematology and Oncology, Inc.

    Danville, Virginia, 24541

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • The Center for Hematology-Oncology

    Delray Beach, Florida, 33484

  • Duluth Clinic

    Duluth, Minnesota, 55805

  • Advance Imaging

    Dunmore, Pennsylvania, 18512

  • Hematology & Oncology Associates of NEPA

    Dunmore, Pennsylvania, 18512

  • Schwartz Gynecologic Oncology

    East Islip, New York, 11730

  • Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • A. Richard Miskoff, DO, PA

    Edison, New Jersey, 08818

  • JFK Medical Center

    Edison, New Jersey, 08818

  • Elkhart General Hospital

    Elkhart, Indiana, 46514

  • Southwest Cancer Care

    Escondido, California, 92025

  • Dakota Cancer Institute

    Fargo, North Dakota, 58103

  • Odyssey Research

    Fargo, North Dakota, 58104

  • University of Connecticut Health Center/John Dempsey Hospital

    Farmington, Connecticut, 06030

  • Joliet Oncology-Hematology Associates, Inc.

    Flossmoor, Illinois, 60422

  • Southern California Permanente Medical Group

    Fontana, California, 92335

  • California Oncology of the Central Valley

    Fresno, California, 93710

  • Gig Harbor Medical Oncology

    Gig Harbor, Washington, 98335

  • Greenville Hospital System

    Greenville, South Carolina, 29605

  • Southern California Permanente Medical Group

    Harbor City, California, 90710

  • Kaiser Permanente Medical Center

    Hayward, California, 94545

  • GYN Oncology Associates, Inc.

    Hollywood, Florida, 33021

  • Kaiser Permanente Hawaii

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • St. Vincent Hospital

    Indianapolis, Indiana, 46260

  • Citrus Hematology and Oncology Center

    Inverness, Florida, 34452

  • Citrus Memorial Hospital Radiology Dept.

    Inverness, Florida, 34452

  • Florida Wellcare Alliance, LC

    Inverness, Florida, 34452

  • Shands Jacksonville Medical Center

    Jacksonville, Florida, 32209

  • Joliet Oncology-Hematology Associates, Inc.

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Inc.

    Joliet, Illinois, 60435

  • Palm Beach Cancer Institute

    Jupiter, Florida, 33458

  • Joliet Oncology-Hematology Associates, Inc.

    Kankakee, Illinois, 60901

  • Gynecologic Oncology Associates

    La Jolla, California, 92037

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • LaPorte Hospital

    La Porte, Indiana, 46350

  • Western Washington Oncology, Inc., P.S.

    Lacey, Washington, 98503

  • Sparrow Health System

    Lansing, Michigan, 48912

  • Southeastern Gynecologic Oncology

    Lawrenceville, Georgia, 30045

  • Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Cancer and Blood Disease Center

    Lecanto, Florida, 34461

  • Little Rock Hematology Oncology

    Little Rock, Arkansas, 72117

  • Arkansas Oncology Associates

    Little Rock, Arkansas, 72205

  • Little Rock Hematology Oncology

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Arkansas Oncology Associates

    Little Rock, Arkansas, 72207

  • LLU Faculty Medical Offices

    Loma Linda, California, 92354

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • Southern California Permanente Medical Group

    Los Angeles, California, 90034

  • Bowyer Oncology Center

    Los Angeles, California, 90095

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • OB/GYN Consult Suite

    Los Angeles, California, 90095

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • University Medical Center, Inc. DBA: U of L Hospital

    Louisville, Kentucky, 40202

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Southeastern Gynecologic Oncology

    Marietta, Georgia, 30060

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Hillcrest Hospital/Cleveland Clinic Health System

    Mayfield Heights, Ohio, 44124

  • The Family Cancer Center

    Memphis, Tennessee, 38119

  • OncRx (Pharmacy)

    Metairie, Louisiana, 70002

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Beverly Oncology and Imaging

    Montebello, California, 90640

  • Clinical Trials and Research Associates, Inc.

    Montebello, California, 90640

  • Oncology Care Medical Associates

    Montebello, California, 90640

  • Joliet Oncology-Hematology Associates, Inc.

    Morris, Illinois, 60450

  • Southwest Cancer Care

    Murrieta, California, 92562

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Hematology-Oncology Associates of Rockland

    New City, New York, 10956

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Hematology and Oncology Specialist

    New Orleans, Louisiana, 70006

  • Newport Imaging Center

    Newport Beach, California, 92660

  • Gynecologic Oncology Associates

    Newport Beach, California, 92663

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Lakeland Hospital

    Niles, Michigan, 49120

  • The Union State Bank Cancer Center

    Nyack, New York, 10960

  • Kaiser Permanente Medical Center

    Oakland, California, 94611

  • N. County Oncology Medical

    Oceanside, California, 92056

  • The Family Cancer Center

    Olive Branch, Mississippi, 38654

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Hematology & Oncology Consultants, PC

    Omaha, Nebraska, 68122

  • Florida Hospital

    Orlando, Florida, 32803

  • Gynecology Oncology

    Orlando, Florida, 32804

  • Florida Hospital Memorial Division - Cancer Care Center

    Ormond Beach, Florida, 32174

  • Florida Hospital Memorial System

    Ormond Beach, Florida, 32174

  • Palm Beach Cancer Institute

    Palm Beach Gardens, Florida, 33410

  • Southern California Permanente Medical Group

    Panorama City, California, 91402

  • GYN Oncology Associates, Inc.

    Pembroke Pines, Florida, 33028

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Texas Cancer Associates

    Plano, Texas, 75093

  • Maine Medical Center - Brighton Campus

    Portland, Maine, 04102

  • Maine Medical Center

    Portland, Maine, 04102

  • Kaiser Permanente Northwest Region

    Portland, Oregon, 97227

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Southwest Cancer Care

    Poway, California, 92064

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Center for Oncology Research and Treatment, PA

    Richardson, Texas, 75080

  • VCU Health System at Stony Point

    Richmond, Virginia, 23235

  • VCU Health System-Dalton Oncology Clinic, North Hospital

    Richmond, Virginia, 23298

  • Southeastern Gynecologic Oncology

    Riverdale, Georgia, 30274

  • Southern California Permanente Medical Group

    Riverside, California, 92505

  • Carilion GYN Oncology Associates

    Roanoke, Virginia, 24014

  • Kaiser Permanente Medical Center

    Sacramento, California, 95825

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Medical Oncology Associates

    San Diego, California, 92123

  • Sharp Memorial Hospital - Investigational Pharmacy

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • Kaiser Permanente Medical Center

    San Francisco, California, 94115

  • Oncology Care Medical Associates

    San Gabriel, California, 91776

  • Kaiser Permanente Medical Center

    San Jose, California, 95119

  • Kaiser Permanente Medical Center

    Santa Clara, California, 95051

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Maine Medical Center - Scarborough Campus

    Scarborough, Maine, 04074

  • Horizons West Medical Group

    Scottsbluff, Nebraska, 69361

  • Odyssey Research

    Scottsbluff, Nebraska, 69361

  • Regional West Medical Center

    Scottsbluff, Nebraska, 69361

  • The Women's Center of Western Nebraska

    Scottsbluff, Nebraska, 69361

  • Hematology & Oncology Associates of NEPA

    Scranton, Pennsylvania, 18508

  • Viewmont Medical Services

    Scranton, Pennsylvania, 18508

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Mercy Health Partners

    Scranton, Pennsylvania, 18510

  • Moses Taylor Hospital

    Scranton, Pennsylvania, 18510

  • Western Washington Oncology, Inc., P.S.

    Shelton, Washington, 98584

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Sioux Valley Clinic - Clinical Research Center

    Sioux Falls, South Dakota, 57104

  • Sioux Valley Clinic Oncology

    Sioux Falls, South Dakota, 57104

  • Sioux Valley Hospital - North Center Radiology

    Sioux Falls, South Dakota, 57104

  • Sioux Valley Clinic OBGYN, Ltd.

    Sioux Falls, South Dakota, 57105

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph's Regional Medical Center

    South Bend, Indiana, 46617

  • Kaiser Permanente Medical Center

    South San Francisco, California, 94080

  • Providence Cancer Institute and Hospital

    Southfield, Michigan, 48075

  • Spartanburg Regional Healthcare System

    Spartanburg, South Carolina, 29303

  • Saint Louis University

    St Louis, Missouri, 63117

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • St. John's Mercy-David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • St. Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Allenmore Hospital - Hematology Oncology Clinic

    Tacoma, Washington, 98405

  • MultiCare Health System - Medical Oncology

    Tacoma, Washington, 98405

  • Garth Phibbs, M.D., FACOG

    Toledo, Ohio, 43606

  • ProMedica Health System

    Toledo, Ohio, 43606

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • Southeastern Gynecologic Oncology

    Tucker, Georgia, 30084

  • Cancer Care Associates

    Tulsa, Oklahoma, 74104

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Associates in Hematology-Oncology, P.C.

    Upland, Pennsylvania, 19013

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

  • Kaiser Permanente Medical Center

    Walnut Creek, California, 94596

  • Diablo Valley Oncology & Hematology Medical Group, Inc.

    Walnut Creek, California, 94598

  • Perceptive Informatics, Inc.

    Waltham, Massachusetts, 02451

  • Marchfield Clinic - Wausau Center

    Wausau, Wisconsin, 54401

  • Palm Beach Cancer Institute

    Wellington, Florida, 33414

  • Jsumc Ob/Gyn

    West Long Branch, New Jersey, 07764

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Mid Onio Onc/Hem (North)

    Westerville, Ohio, 43081

  • Marshfield Clinic Weston Center

    Weston, Wisconsin, 54476

  • Oncology Care Medical Associates

    Whittier, California, 90602

  • Piedmont Hematology Oncology Associates

    Winston-Salem, North Carolina, 27103

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Southern Permanente Medical Group

    Woodland Hills, California, 91367

Other trials in United States

About this 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]

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.

Being tested
TLK286 in Combination with Carboplatin, Doxorubicin HCl Liposome Injection
Keywords
Ovary
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLK286 in Combination with CarboplatinDrug

    Experimental Arm

  • Doxorubicin HCl Liposome InjectionDrug

    Active Comparator

Study groups in NCT00102973
Study groupRoleWhat they receive
TLK286 in Combination with CarboplatinExperimentalNot described
Receives: Drug: TLK286 in Combination with Carboplatin
Doxorubisin HCl Liposome InjectionActive comparatorNot described
Receives: Drug: Doxorubicin HCl Liposome Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Every 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00102973
Sponsor's protocol ID
TLK286.3024
Status last verified
Jun 2006
First submitted
4 Feb 2005
Last updated
31 May 2012
Results posted
No

Publications

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PubMed 37407274

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TLK286 in Combination with Carboplatin and Doxorubicin HCl Liposome Injection in people with Ovarian Neoplasms, run by Telik at 222 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Objectives (time frame: Every 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00102973, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.

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