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

NCT ID: NCT00102973

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TLK286 in Combination with Carboplatin

Group Type EXPERIMENTAL

TLK286 in Combination with Carboplatin

Intervention Type DRUG

Experimental Arm

Doxorubisin HCl Liposome Injection

Group Type ACTIVE_COMPARATOR

Doxorubicin HCl Liposome Injection

Intervention Type DRUG

Active Comparator

Interventions

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TLK286 in Combination with Carboplatin

Experimental Arm

Intervention Type DRUG

Doxorubicin HCl Liposome Injection

Active Comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Telik

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Little Rock Hematology Oncology

Little Rock, Arkansas, United States

Site Status

Arkansas Oncology Associates

Little Rock, Arkansas, United States

Site Status

Little Rock Hematology Oncology

Little Rock, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Arkansas Oncology Associates

Little Rock, Arkansas, United States

Site Status

Southern California Permanente Medical Group

Anaheim, California, United States

Site Status

East Bay Oncology/Hematology Medical Associates, Inc.

Antioch, California, United States

Site Status

Southern California Permanente Medical Group

Baldwin Park, California, United States

Site Status

Southern California Permanente Medical Group

Bellflower, California, United States

Site Status

Marilyn Norton, M.D.

Chula Vista, California, United States

Site Status

Bay Area Cancer Research Group, LLC

Concord, California, United States

Site Status

East Bay Oncology/Hematology Medical Associates, Inc.

Concord, California, United States

Site Status

Southwest Cancer Care

Escondido, California, United States

Site Status

Southern California Permanente Medical Group

Fontana, California, United States

Site Status

California Oncology of the Central Valley

Fresno, California, United States

Site Status

Southern California Permanente Medical Group

Harbor City, California, United States

Site Status

Kaiser Permanente Medical Center

Hayward, California, United States

Site Status

Gynecologic Oncology Associates

La Jolla, California, United States

Site Status

Cancer Center Oncology Medical Group

La Mesa, California, United States

Site Status

LLU Faculty Medical Offices

Loma Linda, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Southern California Permanente Medical Group

Los Angeles, California, United States

Site Status

Southern California Permanente Medical Group

Los Angeles, California, United States

Site Status

Bowyer Oncology Center

Los Angeles, California, United States

Site Status

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Site Status

OB/GYN Consult Suite

Los Angeles, California, United States

Site Status

Beverly Oncology and Imaging

Montebello, California, United States

Site Status

Clinical Trials and Research Associates, Inc.

Montebello, California, United States

Site Status

Oncology Care Medical Associates

Montebello, California, United States

Site Status

Southwest Cancer Care

Murrieta, California, United States

Site Status

Newport Imaging Center

Newport Beach, California, United States

Site Status

Gynecologic Oncology Associates

Newport Beach, California, United States

Site Status

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status

Kaiser Permanente Medical Center

Oakland, California, United States

Site Status

N. County Oncology Medical

Oceanside, California, United States

Site Status

Southern California Permanente Medical Group

Panorama City, California, United States

Site Status

Southwest Cancer Care

Poway, California, United States

Site Status

Southern California Permanente Medical Group

Riverside, California, United States

Site Status

Kaiser Permanente Medical Center

Sacramento, California, United States

Site Status

Medical Oncology Associates

San Diego, California, United States

Site Status

Sharp Memorial Hospital - Investigational Pharmacy

San Diego, California, United States

Site Status

Sharp Rees-Stealy

San Diego, California, United States

Site Status

Kaiser Permanente Medical Center

San Francisco, California, United States

Site Status

Oncology Care Medical Associates

San Gabriel, California, United States

Site Status

Kaiser Permanente Medical Center

San Jose, California, United States

Site Status

Kaiser Permanente Medical Center

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Center

South San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center

Vallejo, California, United States

Site Status

Kaiser Permanente Medical Center

Walnut Creek, California, United States

Site Status

Diablo Valley Oncology & Hematology Medical Group, Inc.

Walnut Creek, California, United States

Site Status

Oncology Care Medical Associates

Whittier, California, United States

Site Status

Southern Permanente Medical Group

Woodland Hills, California, United States

Site Status

University of Connecticut Health Center/John Dempsey Hospital

Farmington, Connecticut, United States

Site Status

The Center for Hematology-Oncology

Boca Raton, Florida, United States

Site Status

Citrus Diagnostic Center

Crystal River, Florida, United States

Site Status

Citrus Hematology and Oncology Center

Crystal River, Florida, United States

Site Status

Citrus Hematology and Oncology Center

Crystal River, Florida, United States

Site Status

The Center for Hematology-Oncology

Delray Beach, Florida, United States

Site Status

GYN Oncology Associates, Inc.

Hollywood, Florida, United States

Site Status

Citrus Hematology and Oncology Center

Inverness, Florida, United States

Site Status

Citrus Memorial Hospital Radiology Dept.

Inverness, Florida, United States

Site Status

Florida Wellcare Alliance, LC

Inverness, Florida, United States

Site Status

Shands Jacksonville Medical Center

Jacksonville, Florida, United States

Site Status

Palm Beach Cancer Institute

Jupiter, Florida, United States

Site Status

Cancer and Blood Disease Center

Lecanto, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Gynecology Oncology

Orlando, Florida, United States

Site Status

Florida Hospital Memorial Division - Cancer Care Center

Ormond Beach, Florida, United States

Site Status

Florida Hospital Memorial System

Ormond Beach, Florida, United States

Site Status

Palm Beach Cancer Institute

Palm Beach Gardens, Florida, United States

Site Status

GYN Oncology Associates, Inc.

Pembroke Pines, Florida, United States

Site Status

Palm Beach Cancer Institute

Wellington, Florida, United States

Site Status

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

Site Status

Southeastern Gynecologic Oncology

Atlanta, Georgia, United States

Site Status

Southeastern Gynecologic Oncology

Lawrenceville, Georgia, United States

Site Status

Southeastern Gynecologic Oncology

Marietta, Georgia, United States

Site Status

Southeastern Gynecologic Oncology

Riverdale, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Southeastern Gynecologic Oncology

Tucker, Georgia, United States

Site Status

Kaiser Permanente Hawaii

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Joliet Oncology-Hematology Associates, Inc.

Flossmoor, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Inc.

Joliet, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Inc.

Joliet, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Inc.

Kankakee, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Inc.

Morris, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

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St. Vincent Hospital

Indianapolis, Indiana, United States

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LaPorte Hospital

La Porte, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Saint Joseph's Regional Medical Center

South Bend, Indiana, United States

Site Status

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

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

Louisville, Kentucky, United States

Site Status

Hematology and Oncology Specialists, LLC

Covington, Louisiana, United States

Site Status

OncRx (Pharmacy)

Metairie, Louisiana, United States

Site Status

Hematology and Oncology Specialist

New Orleans, Louisiana, United States

Site Status

LSU Health Sciences Center

Shreveport, Louisiana, United States

Site Status

Maine Medical Center - Brighton Campus

Portland, Maine, United States

Site Status

Maine Medical Center

Portland, Maine, United States

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Maine Medical Center - Scarborough Campus

Scarborough, Maine, United States

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Sinai Hospital of Baltimore

Baltimore, Maryland, United States

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Center for Cancer and Blood Disorders, P. C.

Bethesda, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber/Partners Cancer Care, Inc.

Boston, Massachusetts, United States

Site Status

Boston Medical Center - Center for Cancer and Blood Disorders

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Perceptive Informatics, Inc.

Waltham, Massachusetts, United States

Site Status

Sparrow Health System

Lansing, Michigan, United States

Site Status

Lakeland Hospital

Niles, Michigan, United States

Site Status

Lakeland Hospital

Saint Joseph, Michigan, United States

Site Status

Providence Cancer Institute and Hospital

Southfield, Michigan, United States

Site Status

Duluth Clinic

Duluth, Minnesota, United States

Site Status

The Family Cancer Center

Olive Branch, Mississippi, United States

Site Status

Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

St. John's Mercy Medical Center

St Louis, Missouri, United States

Site Status

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

St Louis, Missouri, United States

Site Status

Deaconess Billings Clinic

Billings, Montana, United States

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Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Site Status

Hematology & Oncology Consultants, PC

Omaha, Nebraska, United States

Site Status

Horizons West Medical Group

Scottsbluff, Nebraska, United States

Site Status

Odyssey Research

Scottsbluff, Nebraska, United States

Site Status

Regional West Medical Center

Scottsbluff, Nebraska, United States

Site Status

The Women's Center of Western Nebraska

Scottsbluff, Nebraska, United States

Site Status

Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

A. Richard Miskoff, DO, PA

Edison, New Jersey, United States

Site Status

JFK Medical Center

Edison, New Jersey, United States

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Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Jsumc Ob/Gyn

West Long Branch, New Jersey, United States

Site Status

Gynecologic Oncology & Minimally Invasive Surgery

Babylon, New York, United States

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The Mary Imogene Bassett Hospital

Cooperstown, New York, United States

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Schwartz Gynecologic Oncology

East Islip, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Hematology-Oncology Associates of Rockland

New City, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

The Union State Bank Cancer Center

Nyack, New York, United States

Site Status

Asheville Radiology

Asheville, North Carolina, United States

Site Status

Hope A Women's Cancer Center

Asheville, North Carolina, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Inpatient Pharmacy

Charlotte, North Carolina, United States

Site Status

Blumenthal Cancer Center

Charlotte, North Carolina, United States

Site Status

Presbyterian Gynecologic Oncology

Charlotte, North Carolina, United States

Site Status

Presbyterian Hospital

Charlotte, North Carolina, United States

Site Status

Piedmont Hematology Oncology Associates

Winston-Salem, North Carolina, United States

Site Status

Cancer Care Center - Medcenter One, Inc.

Bismarck, North Dakota, United States

Site Status

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

Bismarck, North Dakota, United States

Site Status

Odyssey Research

Bismarck, North Dakota, United States

Site Status

Dakota Cancer Institute

Fargo, North Dakota, United States

Site Status

Odyssey Research

Fargo, North Dakota, United States

Site Status

Barrett Cancer Center

Cincinnati, Ohio, United States

Site Status

UC Physician's Medical Arts Building

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Fairview Hospital Moll Pavilion

Cleveland, Ohio, United States

Site Status

Mid Ohio Onc/Hem (East)

Columbus, Ohio, United States

Site Status

GOPSA

Columbus, Ohio, United States

Site Status

Mid Ohio Onc/Hem (West)

Columbus, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Hillcrest Hospital/Cleveland Clinic Health System

Mayfield Heights, Ohio, United States

Site Status

Garth Phibbs, M.D., FACOG

Toledo, Ohio, United States

Site Status

ProMedica Health System

Toledo, Ohio, United States

Site Status

The Toledo Hospital

Toledo, Ohio, United States

Site Status

Mid Onio Onc/Hem (North)

Westerville, Ohio, United States

Site Status

Cancer Care Associates

Tulsa, Oklahoma, United States

Site Status

Cancer Care Associates

Tulsa, Oklahoma, United States

Site Status

Kaiser Permanente Northwest Region

Portland, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Advance Imaging

Dunmore, Pennsylvania, United States

Site Status

Hematology & Oncology Associates of NEPA

Dunmore, Pennsylvania, United States

Site Status

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Hematology & Oncology Associates of NEPA

Scranton, Pennsylvania, United States

Site Status

Viewmont Medical Services

Scranton, Pennsylvania, United States

Site Status

Community Medical Center

Scranton, Pennsylvania, United States

Site Status

Mercy Health Partners

Scranton, Pennsylvania, United States

Site Status

Moses Taylor Hospital

Scranton, Pennsylvania, United States

Site Status

Associates in Hematology-Oncology, P.C.

Upland, Pennsylvania, United States

Site Status

Roper Hospital-Department of Radiology

Charleston, South Carolina, United States

Site Status

Carolina Center of Gynecologic Oncology, PA

Charleston, South Carolina, United States

Site Status

South Carolina Oncology

Columbia, South Carolina, United States

Site Status

Greenville Hospital System

Greenville, South Carolina, United States

Site Status

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, United States

Site Status

Sioux Valley Clinic - Clinical Research Center

Sioux Falls, South Dakota, United States

Site Status

Sioux Valley Clinic Oncology

Sioux Falls, South Dakota, United States

Site Status

Sioux Valley Hospital - North Center Radiology

Sioux Falls, South Dakota, United States

Site Status

Sioux Valley Clinic OBGYN, Ltd.

Sioux Falls, South Dakota, United States

Site Status

The Family Cancer Center

Bartlett, Tennessee, United States

Site Status

Baroness Erlander Hospital

Chattanooga, Tennessee, United States

Site Status

Chattanooga GYN Oncology

Chattanooga, Tennessee, United States

Site Status

Parkridge Medical Center

Chattanooga, Tennessee, United States

Site Status

The Family Cancer Center

Collierville, Tennessee, United States

Site Status

The Family Cancer Center

Memphis, Tennessee, United States

Site Status

Arlington Cancer Center

Arlington, Texas, United States

Site Status

Center for Oncology Research and Treatment, PA

Dallas, Texas, United States

Site Status

Texas Cancer Associates

Dallas, Texas, United States

Site Status

Texas Cancer Associates

Plano, Texas, United States

Site Status

Center for Oncology Research and Treatment, PA

Richardson, Texas, United States

Site Status

Danville Hematology and Oncology, Inc.

Danville, Virginia, United States

Site Status

VCU Health System at Stony Point

Richmond, Virginia, United States

Site Status

VCU Health System-Dalton Oncology Clinic, North Hospital

Richmond, Virginia, United States

Site Status

Carilion GYN Oncology Associates

Roanoke, Virginia, United States

Site Status

Western Washington Oncology, Inc., P.S.

Aberdeen, Washington, United States

Site Status

Western Washington Oncology, Inc., P. S.

Centralia, Washington, United States

Site Status

Covington MultiCare - Oncology Clinic

Covington, Washington, United States

Site Status

Gig Harbor Medical Oncology

Gig Harbor, Washington, United States

Site Status

Western Washington Oncology, Inc., P.S.

Lacey, Washington, United States

Site Status

Western Washington Oncology, Inc., P.S.

Shelton, Washington, United States

Site Status

Allenmore Hospital - Hematology Oncology Clinic

Tacoma, Washington, United States

Site Status

MultiCare Health System - Medical Oncology

Tacoma, Washington, United States

Site Status

Marshfield Clinic - Chippewa Falls Center

Chippewa Falls, Wisconsin, United States

Site Status

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

Eau Claire, Wisconsin, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, United States

Site Status

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, United States

Site Status

St. Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

Marchfield Clinic - Wausau Center

Wausau, Wisconsin, United States

Site Status

Marshfield Clinic Weston Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37407274 (View on PubMed)

Other Identifiers

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TLK286.3024

Identifier Type: -

Identifier Source: org_study_id

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