Phase II Trial of Locally Advanced/Metastatic Soft Tissue Sarcoma or Advanced/Metastatic Malignant GIST

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.

Conditions

• Sarcoma
• Malignant Gastrointestinal Stromal Tumor

Interventions

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

Sponsors & Collaborators

• Mackay Memorial Hospital

  collaborator OTHER

• Tri-Service General Hospital

  collaborator OTHER

• China Medical University Hospital

  collaborator OTHER

• Kaohsiung Veterans General Hospital.

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• Buddhist Tzu Chi General Hospital

  collaborator OTHER

• National Health Research Institutes, Taiwan

  lead OTHER

Principal Investigators

• Ming-Jer Huang · Mackay Memorial Hospital

• Li-Tzong Chen, PHD · National Health Research Institutes, Taiwan

• Chung- Huang Chan, PHD · National Health Research Institutes, Taiwan

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-12-31

Primary Completion

2010-04-30

Completion

2011-03-31

Countries

• Taiwan

Study Locations