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.
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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