Status:
COMPLETED
Phase II Trial of Locally Advanced/Metastatic Soft Tissue Sarcoma or Advanced/Metastatic Malignant GIST
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Mackay Memorial Hospital
Tri-Service General Hospital
Conditions:
Sarcoma
Malignant Gastrointestinal Stromal Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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, unl...
Detailed Description
Eligibility Criteria: Inclusion criteria: Patients must have a histologically confirmed diagnosis of (1) locally advanced unresectable or metastatic soft tissue sarcoma; or (2) unresectable/metastat...
Eligibility Criteria
Inclusion
- 1.1 Patients must have a histologically confirmed diagnosis of (1) locally advanced unresectable or metastatic soft tissue sarcoma; or (2) unresectable/metastatic GIST previously treated with imatinib mesylate and is documented to have drug resistance to imatinib mesylate treatment defined by tumor progression.
- 1.2 Age greater than or equal to 18 years and younger than or equal to 70 years old.
- 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.
- 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.
- 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.
- 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).
- 1.9 Patients must have adequate renal function with serum creatinine less than or equal to 1.5 mg/dl.
- 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.
- 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
- 2.1 Patients who have prior treatment with gemcitabine or taxane. 5.2.2 Pregnant or breast feeding females. 5.2.3 Active or uncontrolled infection. 5.2.4 Patients with brain or leptomeningeal metastases.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00359333
Start Date
December 1 2006
End Date
March 1 2011
Last Update
October 30 2013
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan