Study Stopped
Business reasons
Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
ASSIST-5
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)
1 other identifier
interventional
244
4 countries
71
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2006
Typical duration for phase_3
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 6, 2006
CompletedFirst Posted
Study publicly available on registry
July 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 27, 2013
November 1, 2013
2.6 years
July 6, 2006
November 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin
Once 244 planned pts. received at least 2 cycles of study treatment(s)
Secondary Outcomes (1)
To evaluate and compare the safety profile of each treatment arm
Any patient who received 1 dose of study treatment(s) will be evaluable for safety.
Study Arms (2)
Telcyta + Liposomal Doxorubicin
EXPERIMENTALTelcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Liposomal Doxorubicin
ACTIVE COMPARATORLiposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Interventions
Day 1 of 28 Day Cycle. 50 mg/m2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teliklead
Study Sites (71)
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
East Bay Medical Oncology/Hematology Medical Associates, Inc.
Antioch, California, 94509, 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
California Oncology of the Central Valley
Fresno, California, 93710, United States
Women's Cancer Research Foundation
Newport Beach, California, 92663, United States
Southwest Cancer Care
Poway, California, 92064, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270, United States
Southern California Permanente Medical Group
San Diego, California, 92120, 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
Gynecologic Oncology Associates, Inc
Hollywood, Florida, 33020, United States
Shands Jacksonville Medical Center
Jacksonville, Florida, 32209, United States
University of Florida College of Medicine-Jacksonville
Jacksonville, Florida, 32209, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Florida Hospital
Orlando, Florida, 32804, United States
Gynecologic Oncology Associates, Inc
Pembroke Pines, Florida, 33028, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Flossmoor Cancer Care (JOHA DBA)
Flossmoor, Illinois, 60422, United States
Joliet Oncology-Hematology Associates
Joliet, Illinois, 60432, United States
Joliet Oncology-Hematology Associates, LTD.
Joliet, Illinois, 60435, United States
Kankakee Cancer Center (JOHA DBA)
Kankakee, Illinois, 60901, United States
Joliet Oncology-Hematology Associates
Morris, Illinois, 60450, 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
Hematology & Oncology Consultants P.C.
Omaha, Nebraska, 68122, United States
Horizon's West Medical Group
Scottsbluff, Nebraska, 69361, United States
The Women's Center of Western Nebraska
Scottsbluff, Nebraska, 69361, United States
Schwaartz Gynecologic Oncology, PLLC
Babylon, New York, 11702, United States
The Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Monter Cancer Center
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Hope A Women's Cancer Center
Asheville, North Carolina, 28816, United States
Blumenthal Cancer Center
Charlotte, North Carolina, 28204, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Piedmont Hematology Oncology Associates-Lexington Satellite
Lexington, North Carolina, 27292, United States
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103, 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
Kaiser Permanente NW, Oncology/Hematology
Portland, Oregon, 97227, United States
Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Associates in Hematolog-Oncology, P.C.
Upland, Pennsylvania, 19013, United States
Carolina Center of Gynecologic Oncology
Charleston, South Carolina, 29407, United States
Palmetto Health Alliance-Richland
Columbia, South Carolina, 29210, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
Arlington Cancer Center
Trophy Club, Texas, 76262, United States
Danville Hematology & Oncology, Inc.
Danville, Virginia, 24541, United States
Carilion GYN Oncology Associates
Roanoke, Virginia, 24014, United States
Algemeen Ziekenhuis Middelheim
Antwerp, B-2020, Belgium
A.Z. Groeninge Oncologish Centrum
Kortrijk, B-8500, Belgium
Universitaire Ziekenhuizen Leuven Dienst Oncologie
Leuven, B3000, Belgium
Hospital Vera Cruz-Instituto de Oncologia
Belo Horizonte, Minas Gerais, 30190-130, Brazil
Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Cerqueria Cesar, São Paulo, 05403-010, Brazil
Fundacao Hospital Amaral Carvalho
Rua Dona Siilveria, São Paulo, 17210-080, Brazil
Guy's & St. Thomas Cancer Centre
London, England, SE19RT, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY, United Kingdom
Related Publications (2)
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.
PMID: 37407274DERIVEDVergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80. doi: 10.1111/igc.0b013e3181daaf59.
PMID: 20973267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gail L. Brown, MD, MBA
Telik
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2006
First Posted
July 11, 2006
Study Start
May 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 27, 2013
Record last verified: 2013-11