A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
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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 |
- Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 570 |
| 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 |
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| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Show 126 Study Locations| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
More Information
Additional 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: | May 17, 2013 |
| 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 May 23, 2013