Back to resultsA Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Primary Purpose
Liposarcoma, Leiomyosarcoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Yondelis
Yondelis
Dexamethasone
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Liposarcoma focused on measuring Trabectedin, Yondelis, ET-743, Ecteinascidin, Anthracycline, Ifosfamide, Dexamethasone, Intravenous, Cancer, Malignant, Metastatic
Eligibility Criteria
Inclusion Criteria: Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread) Have a pathology specimen available for centralized review Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion Have adequate bone marrow, liver and kidney function Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin) Cancer that has metastasized (spread) to the central nervous system Active viral hepatitis or chronic liver disease Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Yondelis weekly schedule
Yondelis once every 3 weeks schedule
Arm Description
Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion.
Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion.
Outcomes
Primary Outcome Measures
Time to Progression- Independent Review
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
Secondary Outcome Measures
Percentage of Participants Objective Response - Independent Review
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Duration of Response - Independent Review
Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.
Progression-Free Survival - Independent Review
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Overall Survival
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Full Information
NCT ID
NCT00060944
First Posted
May 16, 2003
Last Updated
August 28, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
PharmaMar
1. Study Identification
Unique Protocol Identification Number
NCT00060944
Brief Title
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Official Title
A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
PharmaMar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.
Detailed Description
This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liposarcoma, Leiomyosarcoma
Keywords
Trabectedin, Yondelis, ET-743, Ecteinascidin, Anthracycline, Ifosfamide, Dexamethasone, Intravenous, Cancer, Malignant, Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
271 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yondelis weekly schedule
Arm Type
Experimental
Arm Description
Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion.
Arm Title
Yondelis once every 3 weeks schedule
Arm Type
Experimental
Arm Description
Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion.
Intervention Type
Drug
Intervention Name(s)
Yondelis
Intervention Description
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Yondelis
Intervention Description
0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.
Primary Outcome Measure Information:
Title
Time to Progression- Independent Review
Description
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
Time Frame
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Percentage of Participants Objective Response - Independent Review
Description
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Time Frame
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Title
Duration of Response - Independent Review
Description
Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.
Time Frame
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Title
Progression-Free Survival - Independent Review
Description
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Time Frame
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Title
Overall Survival
Description
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Time Frame
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
Have a pathology specimen available for centralized review
Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
Have adequate bone marrow, liver and kidney function
Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
Cancer that has metastasized (spread) to the central nervous system
Active viral hepatitis or chronic liver disease
Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Coeur D Alene
State/Province
Idaho
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United States
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Park Ridge
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Illinois
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United States
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Indianapolis
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Indiana
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United States
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Louisville
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Kentucky
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United States
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Boston
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Massachusetts
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United States
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Ann Arbor
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Michigan
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United States
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Minneapolis
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Minnesota
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United States
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Rochester
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Minnesota
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United States
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Newark
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New Jersey
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United States
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New York
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New York
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United States
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Cleveland
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Ohio
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United States
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Portland
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Oregon
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United States
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Philadelphia
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Pennsylvania
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United States
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Nashville
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Tennessee
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United States
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Houston
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Texas
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United States
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Salt Lake City
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Utah
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United States
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Seattle
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Washington
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United States
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Milwaukee
State/Province
Wisconsin
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United States
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East Melbourne
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Australia
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Newcastle
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Australia
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Perth
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Australia
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Woodville
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Australia
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Leuven
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Belgium
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Calgary
State/Province
Alberta
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Canada
City
London
State/Province
Ontario
Country
Canada
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Ottawa
State/Province
Ontario
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Canada
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Toronto
State/Province
Ontario
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Canada
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Edmonton
Country
Canada
City
Lyon
Country
France
City
Villejuif
Country
France
City
Düsseldorf
Country
Germany
City
Moscow N/A
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Obninsk N/A
Country
Russian Federation
City
Samara N/A
Country
Russian Federation
City
St Petersburg N/A
Country
Russian Federation
City
St Petersburg
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Russian Federation
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Barcelona
Country
Spain
City
Valencia N/A
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19652065
Description
Demetri GD et al. J Clin Oncol. 2009;27(25):4188-96.
Learn more about this trial
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
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