NCT00411047CompletedPhase 2
A Phase II, Open Label Study of Gefitinib (IRESSA) in Treatment-Naïve Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer and Somatic Activating Mutations in the Epidermal Growth Factor Receptor
Massachusetts General Hospital2 sites in 1 country34 target enrollmentStarted: September 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Objective tumor response rate
Study Overview
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with previously untreated stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES:
Primary
- Determine the objective tumor response rate in patients with previously untreated stage IIIB or IV non-small cell lung cancer with somatic activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene treated with gefitinib.
Secondary
- Determine response duration, progression-free survival, and overall survival of patients treated with this drug.
- Determine the safety of this drug in these patients.
- Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict response in patients treated with this drug.
- Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict toxicity of this drug in these patients.
- Define a molecular profile in patients who initially respond to treatment with this drug but subsequently progress on therapy.
- Determine the significance of germline polymorphisms of the EGFR gene, somatic amplification of the EGFR gene, and other molecular factors for their association with clinical outcome parameters in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Objective tumor response rate
Secondary Outcomes
- Molecular profile
- Response duration, progression-free survival, and overall survival
- Safety
- Ability of various somatic activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene to predict response and toxicity
- Significance of germline polymorphisms of the EGFR gene, somatic amplification of the EGFR gene, and other molecular factors for their association with clinical outcome parameters
Investigators
Lecia V. Sequist
Principal Investigator
Massachusetts General Hospital
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 2
Gefitinib as First-Line Therapy Followed by Gemcitabine and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00217698Swiss Cancer Institute63
Withdrawn
Phase 1
Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung CancerNon-small Cell Lung CancerNCT00268255Barbara Ann Karmanos Cancer Institute
Terminated
Phase 2
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By SurgeryEsophageal CancerNCT00258297University of Rochester30
Completed
Phase 2
Gefitinib in Treating Patients With Locally Advanced Esophageal CancerEsophageal CancerNCT00100945Alliance for Clinical Trials in Oncology70
Terminated
Phase 1
Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By SurgeryEsophageal CancerNCT00290719University of California, San Francisco6