TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Soft Tissue Sarcoma
Summary
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Detailed description
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously. A total of 80 patients will receive trabectedin 0.5 mg/m2 as 24 hour continuous intravenous infusion (CIV) on D1 and D8, gemcitabine 200 mg/m2 i.v. on D1 and D8, and dacarbazine 200 mg/m2 i.v. on D1 and D8 (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan/MRI will be replaced.
Arms & interventions
- DrugTrabectedin
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Outcome measures
Primary
Progression free survival
Progression free survival up to disease progression or death from any cause
Time frame: 12 months
Secondary
Overall Response
Time frame: 6 weeks
Adverse Event
Time frame: 12 months
Eligibility criteria
Study locations (1)
Sant P Chawla
Santa Monica, California, 90403
References
- Maiti R. Metronomic chemotherapy. J Pharmacol Pharmacother. 2014 Jul;5(3):186-92. doi: 10.4103/0976-500X.136098.(PubMed)
- www.accessdata.fda.gov/drugsatfda_docs (Trabectedin, Gemcitabine, Dacarbazine)