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Ph 3 Randomized Study of Telcyta® + Liposomal Doxorubicin Vs Liposomal Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

Information source: Telik
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Neoplasms

Intervention: TLK286 (Telcyta) HCI for Injection (Drug); Doxorubicin HCI Liposome Injection (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Telik

Summary

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

Clinical Details

Official title: Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Are a woman 18 years of age or older

- Have histologically or cytologically confirmed epithelial cancer or primary peritoneal

cancer

- Have platinum refractory or resistant cancer

- Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

- Had treatment with first-line chemotherapy other than a platinum-containing regimen

- Have clinically significant cardiac disease

- Have any sign of intestinal obstruction interfering with nutrition

- Are pregnant or lactating

- Had prior treatment with liposomal doxorubicin

- Had prior treatment with Telcyta

Locations and Contacts

Universitaire Ziekenhuizen Leuven Dienst Oncologie, Leuven B3000, Belgium

A.Z. Groeninge Oncologish Centrum, Kortrijk B-8500, Belgium

Algemeen Ziekenhuis Middelheim, Antwerpen B-2020, Belgium

Desert Oasis Cancer Center, Casa Grande, Arizona 85222, United States

Hematology Oncology Services of Arkansas, Little Rock, Arkansas 72205, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Southwest Cancer Care, Poway, California 92064, United States

California Oncology of the Central Valley, Fresno, California 93710, United States

Desert Hematology Oncology Medical Group, Rancho Mirage, California 92270, United States

Women's Cancer Research Foundation, Newport Beach, California 92663, United States

Southern California Permanente Medical Group, San Diego, California 92120, United States

Bay Area Cancer Research Group, LLC, Concord, California 94520, United States

East Bay Medical Oncology/Hematology Medical Associates, Concord, California 94520, United States

East Bay Medical Oncology/Hematology Medical Associates, Inc., Antioch, California 94509, United States

East Bay Medical Oncoogy/Hematology Medical Associates, Inc., San Leandro, California 94578, United States

Diablo Valley Oncology & Hematology Medical Group, Inc., Walnut Creek, California 94598, United States

Guy's & St. Thomas Cancer Centre, London, England SE19RT, United Kingdom

Gynecologic Oncology Associates, Inc, Hollywood, Florida 33020, United States

Gynecologic Oncology Associates, Inc, Pembroke Pines, Florida 33028, United States

Florida Hospital Cancer Institute, Orlando, Florida 32804, United States

Florida Hospital, Orlando, Florida 32804, United States

University of Florida College of Medicine-Jacksonville, Jacksonville, Florida 32209, United States

Shands Jacksonville Medical Center, Jacksonville, Florida 32209, United States

Memorial Health University Medical Center, Savannah, Georgia 31404, United States

Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii 96819, United States

Joliet Oncology-Hematology Associates, LTD., Joliet, Illinois 60435, United States

Joliet Oncology-Hematology Associates, Joliet, Illinois 60432, United States

Joliet Oncology-Hematology Associates, Morris, Illinois 60450, United States

Flossmoor Cancer Care (JOHA DBA), Flossmoor, Illinois 60422, United States

Kankakee Cancer Center (JOHA DBA), Kankakee, Illinois 60901, United States

St. Vincent Gynecologic Oncology, Indianapolis, Indiana 46260, United States

Central Baptist Hospital, Lexington, Kentucky 40503, United States

Hematology and Oncology Specialists, LLC, Metairie, Louisiana 70006, United States

LSU Health Sciences Center, Shreveport, Louisiana 71103, United States

Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States

Arch Medical Services, St. Louis, Missouri 63141, United States

Horizon's West Medical Group, Scottsbluff, Nebraska 69361, United States

The Women's Center of Western Nebraska, Scottsbluff, Nebraska 69361, United States

Hematology & Oncology Consultants P.C., Omaha, Nebraska 68122, United States

Schwaartz Gynecologic Oncology, PLLC, Babylon, New York 11702, United States

The Mary Imogene Bassett Hospital, Cooperstown, New York 13326, United States

Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Monter Cancer Center, Lake Success, New York 11042, United States

Hope A Women's Cancer Center, Asheville, North Carolina 28816, United States

Piedmont Hematology Oncology Associates, Winston Salem, North Carolina 27103, United States

Piedmont Hematology Oncology Associates-Lexington Satellite, Lexington, North Carolina 27292, United States

Presbyterian Hospital, Charlotte, North Carolina 28204, United States

Blumenthal Cancer Center, Charlotte, North Carolina 28204, United States

Carolinas Medical Center, Charlotte, North Carolina 28204, United States

Dakota Cancer Institute/Dakota Clinic Ltd., Fargo, North Dakota 58103, United States

Gynecologic Oncology & Pelvic Surgery Associates, Columbus, Ohio 43222, United States

Garth Phibbs, M.D., FACOG, Toledo, Ohio 43606, United States

The Toledo Hospital, Toledo, Ohio 43606, United States

Oregon Health & Science University, Portland, Oregon 97239-3098, United States

Kaiser Permanente NW, Oncology/Hematology, Portland, Oregon 97227, United States

Hematology & Oncology Associates of NEPA, Dunmore, Pennsylvania 18512, United States

Associates in Hematolog-Oncology, P.C., Upland, Pennsylvania 19013, United States

Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania 15213, United States

Abington Memorial Hospital, Abington, Pennsylvania 19001, United States

Fundacao Hospital Amaral Carvalho, Rua Dona Siilveria, Sao Paulo 17210-080, Brazil

Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Cerqueria Cesar, Sao Paulo 05403-010, Brazil

Ninewells Hospital and Medical School, Dundee, Scotland DD1 9SY, United Kingdom

Carolina Center of Gynecologic Oncology, Charleston, South Carolina 29407, United States

South Carolina Oncology Associates, Columbia, South Carolina 29210, United States

Palmetto Health Alliance-Richland, Columbia, South Carolina 29210, United States

Arlington Cancer Center, Arlington, Texas 76012, United States

Arlington Cancer Center, Trophy Club, Texas 76262, United States

Carilion GYN Oncology Associates, Roanoke, Virginia 24014, United States

Danville Hematology & Oncology, Inc., Danville, Virginia 24541, United States

Hospital Vera Cruz-Instituto de Oncologia, Belo Horizonte, mg 30190-130, Brazil

Additional Information

Starting date: May 2006
Last updated: January 10, 2008

Page last updated: June 20, 2008

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