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