A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pharma Mar, S.A.U.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01343277
First received: April 26, 2011
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).


Condition Intervention Phase
Advanced Liposarcoma or Leiomyosarcoma
Drug: Trabectedin
Drug: Dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • The number of patients with adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 586
Study Start Date: June 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trabectedin Drug: Trabectedin
Type=exactly number, unit=mg/m2, number=1.5, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.
Active Comparator: Dacarbazine Drug: Dacarbazine
Type=exactly number, unit=g/m2, number=1, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.

Detailed Description:

This is a randomized study (study drug assigned by chance) using a 2:1 randomization. It is an open-label (all patients and study staff know the identity of the assigned study drug), active-controlled (comparing to a different drug used for the same condition), parallel-group (different treatment groups continue with separate treatments throughout the study), multicenter study. This study will be divided into three phases, screening, treatment, and follow-up. During screening, potential patients will be assessed for study eligibility after providing signed informed consent. Approximately 570 patients who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n=380) or dacarbazine (n=190) treatment groups. During the treatment phase, patients will receive study drug once every 3 weeks, until disease progression (defined by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1 criteria) or signs of toxicity. Assessments will be performed to evaluate the effectiveness of the drug, and patient safety will be monitored. During the follow-up phase, after the last dose of study drug, clinical outcomes for patients will be evaluated. Trabectedin will be administered at a dose of 1.5 mg/m2 through a catheter into a large vein as a 24-hour intravenous (IV) infusion, once every 3 weeks, until disease progression or signs of toxicity. Dacarbazine will be administered at a dose of 1.0 g/m2 as a 20-120 minute infusion, once every 3 weeks, until disease progression or signs of toxicity.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced or spreading liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) or leiomyosarcoma.
  • Treated in any order with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen.
  • Measurable disease at baseline in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
  • Pathology specimens (eg, tumor blocks or unstained slides) for potential centralized pathology review and biomarker studies.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria:

  • Prior exposure to trabectedin or dacarbazine.
  • Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent.
  • Other malignancy within past 3 years (exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix).
  • Known central nervous system metastasis.
  • Significant chronic liver disease, such as cirrhosis or active viral hepatitis.
  • Heart attack within 6 months before enrollment.
  • Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343277

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Los Angeles, California, United States
Orange, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Stanford, California, United States
United States, Colorado
Aurora, Colorado, United States
Denver, Colorado, United States
United States, Connecticut
Hartford, Connecticut, United States
New Haven, Connecticut, United States
United States, Florida
Boynton Beach, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
Savannah, Georgia, United States
United States, Idaho
Post Falls, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
Naperville, Illinois, United States
Park Ridge, Illinois, United States
Peoria, Illinois, United States
Springfield, Illinois, United States
Warrenville, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
Sioux City, Iowa, United States
United States, Kansas
Overland Park, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
Covington, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Lansing, Michigan, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Saint Joseph, Missouri, United States
Saint Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Henderson, Nevada, United States
Las Vegas, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Newark, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Bronx, New York, United States
Johnson City, New York, United States
New York, New York, United States
Syracuse, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
State College, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Fairfax, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, West Virginia
Morgantown, West Virginia, United States
United States, Wisconsin
Green Bay, Wisconsin, United States
Milwaukee, Wisconsin, United States
Australia
Malvern, Australia
Randwick, Australia
Subiaco, Australia
Woolloongabba, Australia
Brazil
Bahia, Brazil
Barretos, Brazil
Ijuí, Brazil
Porto Alegre, Brazil
Sao Paulo, Brazil
São Paulo, Brazil
New Zealand
Auckland, New Zealand
Wellington, New Zealand
Sponsors and Collaborators
Janssen Research & Development, LLC
Pharma Mar, S.A.U.
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01343277     History of Changes
Other Study ID Numbers: CR018004, ET743SAR3007
Study First Received: April 26, 2011
Last Updated: March 16, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Health Research Council
South Africa: Medicines Control Council
Brazil: Ministry of Health

Keywords provided by Janssen Research & Development, LLC:
Advanced Liposarcoma or Leiomyosarcoma
Trabectedin
Yondelis
Dacarbazine
Anthracycline
L-sarcoma

Additional relevant MeSH terms:
Leiomyosarcoma
Liposarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Adipose Tissue
Dacarbazine
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014