Phase II Trial of Locally Advanced/Metastatic Soft Tissue Sarcoma or Advanced/Metastatic Malignant GIST (STS)
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.
Malignant Gastrointestinal Stromal Tumor
Drug: Gemcitabine , Docetaxel
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multiple Centers, Prospective, Phase II Trial of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Locally Advanced/Metastatic Soft Tissue Sarcoma or Imatinib Mesylate Refractory Advanced/Metastatic Malignant Gastrointestinal Stromal Tumor|
- Tumor response [ Time Frame: CT scan are repeated after every 3 courses of chemotherapy. Patients who complete at least two courses of chemotherapy are eligible for evaluating response. ] [ Designated as safety issue: Yes ]
- Time to tumor progression Overall survival Quality of life [ Time Frame: Evaluable for toxicity if they received at least one dose of study medication. ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Study Completion Date:||March 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
|Experimental: Single Group||
Drug: Gemcitabine , Docetaxel
Gemcitabine 800 mg/m2 IV over 80 minutes on day 1 and day 8, and Docetaxel 60 mg/m2 IV over 60 minutes on day 1 of a 21-day cycle
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00359333
|China Medical University Hospital|
|Principal Investigator:||Ming-Jer Huang||Mackay Memorial Hospital|
|Principal Investigator:||Li-Tzong Chen, PHD||National Health Research Institutes, Taiwan|
|Principal Investigator:||Chung- Huang Chan, PHD||National Health Research Institutes, Taiwan|