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Sarcoma

Trabectedin or Dacarbazine Advanced L-Sarcoma (20110545)
A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma Previously Treated With an Anthracycline and Ifosfamide
Status Conditions Phase Study ID
Recruiting Liposarcoma
Leiomyosarcoma
Phase III 20110545
NCT01343277
Summary

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.


Investigator
Robin L. Jones, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
November 23, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.