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

Primary Purpose

Ovarian Neoplasms

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telcyta
Liposomal Doxorubicin
Sponsored by
Telik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Ovary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Desert Oasis Cancer Center
  • Hematology Oncology Services of Arkansas
  • University of Arkansas for Medical Sciences
  • East Bay Medical Oncology/Hematology Medical Associates, Inc.
  • Bay Area Cancer Research Group, LLC
  • East Bay Medical Oncology/Hematology Medical Associates
  • California Oncology of the Central Valley
  • Women's Cancer Research Foundation
  • Southwest Cancer Care
  • Desert Hematology Oncology Medical Group
  • Southern California Permanente Medical Group
  • East Bay Medical Oncoogy/Hematology Medical Associates, Inc.
  • Diablo Valley Oncology & Hematology Medical Group, Inc.
  • Gynecologic Oncology Associates, Inc
  • Shands Jacksonville Medical Center
  • University of Florida College of Medicine-Jacksonville
  • Florida Hospital Cancer Institute
  • Florida Hospital
  • Gynecologic Oncology Associates, Inc
  • Memorial Health University Medical Center
  • Kaiser Permanente Moanalua Medical Center
  • Flossmoor Cancer Care (JOHA DBA)
  • Joliet Oncology-Hematology Associates
  • Joliet Oncology-Hematology Associates, LTD.
  • Kankakee Cancer Center (JOHA DBA)
  • Joliet Oncology-Hematology Associates
  • St. Vincent Gynecologic Oncology
  • Central Baptist Hospital
  • Hematology and Oncology Specialists, LLC
  • LSU Health Sciences Center
  • Center for Cancer and Blood Disorders
  • Arch Medical Services
  • Hematology & Oncology Consultants P.C.
  • Horizon's West Medical Group
  • The Women's Center of Western Nebraska
  • Schwaartz Gynecologic Oncology, PLLC
  • The Mary Imogene Bassett Hospital
  • Monter Cancer Center
  • North Shore University Hospital
  • Long Island Jewish Medical Center
  • Hope A Women's Cancer Center
  • Blumenthal Cancer Center
  • Carolinas Medical Center
  • Presbyterian Hospital
  • Piedmont Hematology Oncology Associates-Lexington Satellite
  • Piedmont Hematology Oncology Associates
  • Dakota Cancer Institute/Dakota Clinic Ltd.
  • Gynecologic Oncology & Pelvic Surgery Associates
  • Garth Phibbs, M.D., FACOG
  • The Toledo Hospital
  • Kaiser Permanente NW, Oncology/Hematology
  • Oregon Health & Science University
  • Abington Memorial Hospital
  • Hematology & Oncology Associates of NEPA
  • Magee Women's Hospital of UPMC
  • Associates in Hematolog-Oncology, P.C.
  • Carolina Center of Gynecologic Oncology
  • Palmetto Health Alliance-Richland
  • South Carolina Oncology Associates
  • Arlington Cancer Center
  • Arlington Cancer Center
  • Danville Hematology & Oncology, Inc.
  • Carilion GYN Oncology Associates
  • Algemeen Ziekenhuis Middelheim
  • A.Z. Groeninge Oncologish Centrum
  • Universitaire Ziekenhuizen Leuven Dienst Oncologie
  • Hospital Vera Cruz-Instituto de Oncologia
  • Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  • Fundacao Hospital Amaral Carvalho
  • Guy's & St. Thomas Cancer Centre
  • Ninewells Hospital and Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telcyta + Liposomal Doxorubicin

Liposomal Doxorubicin

Arm Description

Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle

Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle

Outcomes

Primary Outcome Measures

To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin

Secondary Outcome Measures

To evaluate and compare the safety profile of each treatment arm

Full Information

First Posted
July 6, 2006
Last Updated
November 26, 2013
Sponsor
Telik
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1. Study Identification

Unique Protocol Identification Number
NCT00350948
Brief Title
Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
Acronym
ASSIST-5
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telik

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
Keywords
Ovary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telcyta + Liposomal Doxorubicin
Arm Type
Experimental
Arm Description
Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Arm Title
Liposomal Doxorubicin
Arm Type
Active Comparator
Arm Description
Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Telcyta
Other Intervention Name(s)
TLK286, canfosfamide
Intervention Description
Day 1 of 28 day Cycle.
Intervention Type
Drug
Intervention Name(s)
Liposomal Doxorubicin
Other Intervention Name(s)
Doxil, Caelyx
Intervention Description
Day 1 of 28 Day Cycle. 50 mg/m2
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L. Brown, MD, MBA
Organizational Affiliation
Telik
Official's Role
Study Director
Facility Information:
Facility Name
Desert Oasis Cancer Center
City
Casa Grande
State/Province
Arizona
ZIP/Postal Code
85222
Country
United States
Facility Name
Hematology Oncology Services of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
East Bay Medical Oncology/Hematology Medical Associates, Inc.
City
Antioch
State/Province
California
ZIP/Postal Code
94509
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
East Bay Medical Oncology/Hematology Medical Associates
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
California Oncology of the Central Valley
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Women's Cancer Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Southwest Cancer Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
East Bay Medical Oncoogy/Hematology Medical Associates, Inc.
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Diablo Valley Oncology & Hematology Medical Group, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Gynecologic Oncology Associates, Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
Shands Jacksonville Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Florida College of Medicine-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Gynecologic Oncology Associates, Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Kaiser Permanente Moanalua Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Flossmoor Cancer Care (JOHA DBA)
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Joliet Oncology-Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, LTD.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Kankakee Cancer Center (JOHA DBA)
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Facility Name
Joliet Oncology-Hematology Associates
City
Morris
State/Province
Illinois
ZIP/Postal Code
60450
Country
United States
Facility Name
St. Vincent Gynecologic Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Hematology and Oncology Specialists, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Arch Medical Services
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hematology & Oncology Consultants P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Horizon's West Medical Group
City
Scottsbluff
State/Province
Nebraska
ZIP/Postal Code
69361
Country
United States
Facility Name
The Women's Center of Western Nebraska
City
Scottsbluff
State/Province
Nebraska
ZIP/Postal Code
69361
Country
United States
Facility Name
Schwaartz Gynecologic Oncology, PLLC
City
Babylon
State/Province
New York
ZIP/Postal Code
11702
Country
United States
Facility Name
The Mary Imogene Bassett Hospital
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Hope A Women's Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28816
Country
United States
Facility Name
Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Piedmont Hematology Oncology Associates-Lexington Satellite
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27292
Country
United States
Facility Name
Piedmont Hematology Oncology Associates
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dakota Cancer Institute/Dakota Clinic Ltd.
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Gynecologic Oncology & Pelvic Surgery Associates
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Garth Phibbs, M.D., FACOG
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Kaiser Permanente NW, Oncology/Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Hematology & Oncology Associates of NEPA
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
Magee Women's Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Associates in Hematolog-Oncology, P.C.
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Carolina Center of Gynecologic Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Palmetto Health Alliance-Richland
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Arlington Cancer Center
City
Trophy Club
State/Province
Texas
ZIP/Postal Code
76262
Country
United States
Facility Name
Danville Hematology & Oncology, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Carilion GYN Oncology Associates
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerpen
ZIP/Postal Code
B-2020
Country
Belgium
Facility Name
A.Z. Groeninge Oncologish Centrum
City
Kortrijk
ZIP/Postal Code
B-8500
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven Dienst Oncologie
City
Leuven
ZIP/Postal Code
B3000
Country
Belgium
Facility Name
Hospital Vera Cruz-Instituto de Oncologia
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30190-130
Country
Brazil
Facility Name
Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Cerqueria Cesar
State/Province
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Fundacao Hospital Amaral Carvalho
City
Rua Dona Siilveria
State/Province
Sao Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Guy's & St. Thomas Cancer Centre
City
London
State/Province
England
ZIP/Postal Code
SE19RT
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20973267
Citation
Vergote 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.
Results Reference
derived

Learn more about this trial

Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

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