Trial Information

A Phase I Study to Determine the Dose of the Combination of Yondelis and Doxorubicin for Which Neutropenia is Manageable With the Support of Granulocyte-Colony Stimulation Factor in Subjects With Recurrent or Persistent Soft Tissue Sarcoma

This is a multicenter, open-label (identity of the assigned study treatments will be known
to patients and study staff) study to determine the dose of the combination of trabectedin
(Yondelis) and Doxorubicin for which the neutropenia (low white blood cell counts) is
manageable with the use of filgrastim (an agent used to manage neutropenia) and associated
with clinically acceptable number of side effects severe enough to continuation of treatment
in patients with recurrent or persistent soft tissue sarcoma (STS, a malignant tumor that
attacks the body's infrastructure of fat, muscles, nerves, joints, blood vessels, or deep
skin tissues). Patients will be enrolled in the study after all study-specific entry
criteria are met and informed consent is obtained. Patients will be required to attend
regular clinic visits to receive study medication and have their status monitored. A
detailed explanation can be provided by the study physician (Investigator) conducting this
study. Doxorubicin (50 to 75 mg/m2) will be given as a 10-15 minute intravenous (i.v.)
infusion on Day 1 via a central venous catheter which is a tube placed into a large vein.
Trabectedin (0.9 to 1.3 mg/m2) will be given as a 3 hour i.v. infusion, immediately
following the administration of doxorubicin. Dexamethasone 20 mg will be given within 1 hour
before the start of each doxorubicin i.v. infusion and filgrastim will be administered
according to manufacturer's instructions.