Phase II Trial of Locally Advanced/Metastatic Soft Tissue Sarcoma or Advanced/Metastatic Malignant GIST
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
Study Design Type of Study This is an open-label, single arm, prospective, multiple-center
phase II study
Duration of the Study Period in One Subject Treatment duration is planned for six cycles,
unless there is evidence of disease progression or unacceptable toxicity. Patients with
continued response after six cycles could receive two additional cycles of therapy. In case
complete response and in the absence of unacceptable toxicity, treatment will be continued
for at least 2 further cycles to achieve the minimal of 6 total cycles.
Study Objectives Primary Objective The primary objective is to determine the response rate of
sequential gemcitabine and docetaxel combination in patients with locally advanced/metastatic
soft tissue sarcoma or imatinib mesylate refractory GIST.
Secondary Objectives The secondary objectives of this study are to determine the time to
progression in patients treated with this regimen, the toxicity of this regimen in these
patients, the overall survival and the quality of life.
Molecular analysis of genetic aberration in soft tissue sarcoma The genetic aberrations of
soft tissue sarcoma as reported in literature will be determined. The genetic aberration will
be correlated to chemotherapy responses.
c-kit and PDGFR gene mutations induced by imatinib mesylate and chemotherapy Those acquired
gene mutation of c-kit and PGDFR induced by imatinib mesylate will be first determined. We
will also examine further gene mutation of c-kit and PGDFR caused by combination
chemotherapy.
Phase:
Phase 2
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Buddhist Tzu Chi General Hospital China Medical University Hospital Kaohsiung Veterans General Hospital. Mackay Memorial Hospital Taichung Veterans General Hospital Tri-Service General Hospital