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| Sponsor: | National Health Research Institutes, Taiwan |
|---|---|
| Collaborators: |
Mackay Memorial Hospital Tri-Service General Hospital China Medical University Hospital Kaohsiung Veterans General Hospital. Taichung Veterans General Hospital Buddhist Tzu Chi General Hospital |
| Information provided by: | National Health Research Institutes, Taiwan |
| ClinicalTrials.gov Identifier: | NCT00359333 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma Malignant Gastrointestinal Stromal Tumor |
Drug: Gemcitabine , Docetaxel |
Phase II |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 88 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
5.1.2 Age greater than or equal to 18 years and younger than or equal to 70 years old.
5.1.3 Measurable disease: defined as lesions that can be measured in at least one dimension by physical examination or medical imaging techniques. Ascites, pleural effusions, and bone marrow disease will not considered measurable disease.
5.1.4 Patients must have an ECOG performance status of less than or equal to 2. 5.1.5 Patients must have recovered (defined as toxicity less than grade 2) from toxic effects of all prior therapy before entering onto study.
5.1.6 A treatment of drug free interval of at least 4 weeks since the last dose of chemotherapy or imatinib mesylate therapy is required.
5.1.7 More than 4 weeks since prior radiotherapy is required. 5.1.8 Adequate bone marrow function with an ANC greater than or equal to 1,500/ml, platelet count greater than or equal to 100,000/ ml (transfusion independent) and hemoglobin greater than or equal to 8.0 g/dl (transfusions permitted).
5.1.9 Patients must have adequate renal function with serum creatinine less than or equal to 1.5 mg/dl.
5.1.10 Patients must have adequate liver function, defined as bilirubin within 1.5 times the upper limit of normal, and liver transaminases within 2.5 times the upper limit of normal.
5.1.11 All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.
Exclusion Criteria:
Contacts and Locations| Contact: Chung-Huang Chan | 886-2-87923311 ext 17621 | hubertchan@nhri.org.tw |
| Contact: Yung-Hsin Chin | 886-2-87923311 ext 17643 | yhchin@nhri.org.tw |
| Taiwan | |
| China Medical University Hospital | Recruiting |
| Taichung, Taiwan | |
| Contact: Chunghuang Chan, PHD 886-2-28712121 ext 3813 hubertchan@nhri.org.tw | |
| Contact: Fang Chiu Chang 886-4-22052121 ext 2010 d5686@www.cmuh.org.tw | |
| Principal Investigator: Chang-Fang Chiu | |
| 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 |
More Information
| Responsible Party: | Yung-Hsin Chin, Research Nurse, National Health Research Institutes, Taiwan Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00359333 History of Changes |
| Other Study ID Numbers: | T1706 |
| Study First Received: | August 1, 2006 |
| Last Updated: | July 2, 2009 |
| Health Authority: | Taiwan: Department of Health |
|
Gastrointestinal Stromal Tumors Sarcoma Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Gemcitabine Docetaxel Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |