A Phase III Study of Trabectedin or Dacarbazine for Previously Treated Advanced Liposarcoma or Leiomyosarcoma

Protocol
11-143
Full Title
A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
Purpose

The purpose of this study is to compare the effectiveness of the investigational drug trabectedin (Yondelis) with that of dacarbazine in patients with advanced liposarcoma or leiomyosarcoma that has continued to grow or has returned despite therapy with an anthracycline (such as doxorubicin, also known as Adriamycin).

Trabectedin may stop cancer cells from growing by binding to DNA in cancer cells. Dacarbazine is commonly used to treat liposarcoma and leiomyosarcoma. In this study, patients will be randomly assigned to receive trabectedin or dacarbazine, but not both. Each patient has a two out of three chance of receiving trabectedin and a one in three chance of receiving dacarbazine.

Investigator
Martee L. Hensley, MD
Martee L. Hensley - Physician Profile
Co-Investigators
Mary Louise Keohan, MD
Mary Louise Keohan - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced liposarcoma or leiomyosarcoma that has continued to grow or has returned despite prior therapy with an anthracycline.
  • Patients must have disease that can be seen and measured on a CT scan.
  • At least 3 weeks must have passed since the completion of prior treatment and entry into the study.
  • Patients who receive trabectedin must have a permanent intravenous access port (such as a Mediport) already in place, or must agree to have one placed prior to the start of treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 15 or older.

For more information about this study or to inquire about eligibility, please contact Dr. Martee L. Hensley at 646-888-4222.

Disease(s)
Endometrial and other Uterine Cancers: Leiomyosarcoma
Leiomyosarcoma
Sarcomas
Sarcomas: Leiomyosarcoma
Sarcomas: Soft Tissue Sarcoma
Locations
ClinicalTrials.gov
Related Diseases

Clinical Trials

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