Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

November 26, 2013 updated by: Telik

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, B-2020
        • Algemeen Ziekenhuis Middelheim
      • Kortrijk, Belgium, B-8500
        • A.Z. Groeninge Oncologish Centrum
      • Leuven, Belgium, B3000
        • Universitaire Ziekenhuizen Leuven Dienst Oncologie
  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30190-130
        • Hospital Vera Cruz-Instituto de Oncologia
    • Sao Paulo
      • Cerqueria Cesar, Sao Paulo, Brazil, 05403-010
        • Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
      • Rua Dona Siilveria, Sao Paulo, Brazil, 17210-080
        • Fundacao Hospital Amaral Carvalho
  • United Kingdom
    • England
      • London, England, United Kingdom, SE19RT
        • Guy's & St. Thomas Cancer Centre
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
  • United States
    • Arizona
      • Casa Grande, Arizona, United States, 85222
        • Desert Oasis Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Hematology Oncology Services of Arkansas
    • California
      • Antioch, California, United States, 94509
        • East Bay Medical Oncology/Hematology Medical Associates, Inc.
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group, LLC
      • Concord, California, United States, 94520
        • East Bay Medical Oncology/Hematology Medical Associates
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • Newport Beach, California, United States, 92663
        • Women's Cancer Research Foundation
      • Poway, California, United States, 92064
        • Southwest Cancer Care
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group
      • San Diego, California, United States, 92120
        • Southern California Permanente Medical Group
      • San Leandro, California, United States, 94578
        • East Bay Medical Oncoogy/Hematology Medical Associates, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Valley Oncology & Hematology Medical Group, Inc.
    • Florida
      • Hollywood, Florida, United States, 33020
        • Gynecologic Oncology Associates, Inc
      • Jacksonville, Florida, United States, 32209
        • Shands Jacksonville Medical Center
      • Jacksonville, Florida, United States, 32209
        • University of Florida College of Medicine-Jacksonville
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, United States, 32804
        • Florida Hospital
      • Pembroke Pines, Florida, United States, 33028
        • Gynecologic Oncology Associates, Inc
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Flossmoor Cancer Care (JOHA DBA)
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Ltd.
      • Joliet, Illinois, United States, 60432
        • Joliet Oncology-Hematology Associates
      • Kankakee, Illinois, United States, 60901
        • Kankakee Cancer Center (JOHA DBA)
      • Morris, Illinois, United States, 60450
        • Joliet Oncology-Hematology Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Gynecologic Oncology
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Hematology And Oncology Specialists, Llc
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Arch Medical Services
    • Nebraska
      • Omaha, Nebraska, United States, 68122
        • Hematology & Oncology Consultants P.C.
      • Scottsbluff, Nebraska, United States, 69361
        • Horizon's West Medical Group
      • Scottsbluff, Nebraska, United States, 69361
        • The Women's Center of Western Nebraska
    • New York
      • Babylon, New York, United States, 11702
        • Schwaartz Gynecologic Oncology, PLLC
      • Cooperstown, New York, United States, 13326
        • The Mary Imogene Bassett Hospital
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28816
        • Hope A Women's Cancer Center
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
      • Charlotte, North Carolina, United States, 28204
        • Blumenthal Cancer Center
      • Lexington, North Carolina, United States, 27292
        • Piedmont Hematology Oncology Associates-Lexington Satellite
      • Winston Salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology Associates
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Dakota Cancer Institute/Dakota Clinic Ltd.
    • Ohio
      • Columbus, Ohio, United States, 43222
        • Gynecologic Oncology & Pelvic Surgery Associates
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital
      • Toledo, Ohio, United States, 43606
        • Garth Phibbs, M.D., FACOG
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente NW, Oncology/Hematology
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Dunmore, Pennsylvania, United States, 18512
        • Hematology & Oncology Associates of NEPA
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital of UPMC
      • Upland, Pennsylvania, United States, 19013
        • Associates in Hematolog-Oncology, P.C.
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Carolina Center of Gynecologic Oncology
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates
      • Columbia, South Carolina, United States, 29210
        • Palmetto Health Alliance-Richland
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
      • Trophy Club, Texas, United States, 76262
        • Arlington Cancer Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Hematology & Oncology, Inc.
      • Roanoke, Virginia, United States, 24014
        • Carilion GYN Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telcyta + Liposomal Doxorubicin
Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Drug: Telcyta
Day 1 of 28 day Cycle.
Other Names:
  • TLK286
  • canfosfamide
Drug: Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Other Names:
  • Caelyx
  • Doxil
Active Comparator: Liposomal Doxorubicin
Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Drug: Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Other Names:
  • Caelyx
  • Doxil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin
Time Frame: Once 244 planned pts. received at least 2 cycles of study treatment(s)
Once 244 planned pts. received at least 2 cycles of study treatment(s)

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare the safety profile of each treatment arm
Time Frame: Any patient who received 1 dose of study treatment(s) will be evaluable for safety.
Any patient who received 1 dose of study treatment(s) will be evaluable for safety.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telik

Investigators

  • Study Director: Gail L. Brown, MD, MBA, Telik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 10, 2006

First Posted (Estimate)

July 11, 2006

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLK286.3025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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