A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
Soft Tissue Sarcoma, Sarcoma, Neoplasms, Connective and Soft Tissue
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Doxorubicin, Adriamycin, Trabectedin, Yondelis, Ecteinascidin 743, Filgrastim, Antineoplastic, Antineoplastic Agents, Pharmacologic Actions, Alkylating Agents
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of soft tissue sarcoma, recurrent or persistent Signed informed consent obtained for all patients before performing any study-related procedures Exclusion Criteria: Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy) Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin Less than 4 weeks since radiation therapy Known metastases (spread) of cancer to the central nervous system Other ongoing serious illness present at the time of enrollment as determined by the Investigator
Sites / Locations
Arms of the Study
Arm 1
Experimental
Trabectedin and doxorubicin
Doxorubicin (50 to 75 mg/m2) administered intravenously on Day 1 followed by trabectedin (0.9 to 1.3 mg/m2) administered intravenously on Day 1 every 3 weeks for up to 6 cycles. Dexamethasone 20 mg administered intravenously will be given within 1 hour before the start of doxorubicin. Patients may receive filgrastim for unmanageable neutropenia.