A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced L-sarcoma

Status: Recruiting
Phase:
Diagnosis: Sarcoma
NCT ID: NCT01343277 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-119

 

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) who were previously treated with an anthracycline and ifosfamide.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
George Demetri, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Edwin Choy, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Melissa Hohos, mhohos@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Mark Morley, mmorley@partners.org

Eligibility Criteria

Inclusion Criteria: - Locally advanced or spreading liposarcoma or leiomyosarcoma that has been diagnosed through tissue analysis and is unable to be removed by surgery - Treated with an anthracycline and ifosfamide administered either in combination or as sequential regimens - ¿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 - Active liver disease, such as chronic viral hepatitis or cirrhosis - 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
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