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

NCT00359333 | Completed Phase 2 DMC

• 1 other identifier: T1706
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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, 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

Outcome Measures

Primary Outcomes (1)

• Tumor response

  CT scan are repeated after every 3 courses of chemotherapy. Patients who complete at least two courses of chemotherapy are eligible for evaluating response.

Secondary Outcomes (1)

• Time to tumor progression Overall survival Quality of life

  Evaluable for toxicity if they received at least one dose of study medication.

Study Arms (1)

Single Group

EXPERIMENTAL

Drug: Gemcitabine , Docetaxel

Interventions

Gemcitabine , Docetaxel DRUG

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

Single Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age greater than or equal to 18 years and younger than or equal to 70 years old.
• 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.
• 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.
• A treatment of drug free interval of at least 4 weeks since the last dose of chemotherapy or imatinib mesylate therapy is required.
• 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).
• Patients must have adequate renal function with serum creatinine less than or equal to 1.5 mg/dl.
• 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.
• All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Mackay Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator
• China Medical University Hospital: collaborator
• Kaohsiung Veterans General Hospital.: collaborator
• Taichung Veterans General Hospital: collaborator
• Buddhist Tzu Chi General Hospital: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Sarcoma; Gastrointestinal Stromal Tumors

Interventions

Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: December 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

TW (1)