A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- To assess the response rate to gefitinib treatment as preoperative induction therapy in
patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer
accompanied by epidermal growth factor receptor (EGFR) mutations.
Secondary
- To determine the complete resection rate in patients treated with this drug.
- To determine the overall survival rate in patients treated with this drug.
- To determine the disease-free survival rate in patients treated with this drug.
- To determine the pathologic complete response rate in patients treated with this drug.
- To determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for
up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with resectable disease may undergo surgery.
Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.
After completion of study therapy, patients are followed for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer
- pN2 disease proven by mediastinoscopy
- Meets any of the following criteria:
- Never smoked
- EGFR mutations (in exon 18, 19, or 21)*
- FISH positive for EGFR* NOTE: *Irrespective of smoking history
- Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan,
according to RECIST
- Feasible to undergo pneumonectomy or lobectomy
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-1
- FEV_1 ≥ 2.0 L in preoperative pulmonary function test
- Hemoglobin ≥ 9.0 g/dL
- WBC 4,000-12,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3.0 times ULN
- AST and ALT ≤ 3.0 times ULN
- Creatinine ≤ 1.5 times ULN
- Negative pregnancy test
Exclusion criteria:
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or
basal/squamous cell skin carcinoma
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy, chemotherapy, hormone therapy, or target therapy
- No other concurrent systemic anticancer therapies, including experimental drugs,
chemotherapy, immunotherapy, or radiotherapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Joo-Hang Kim, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Yonsei University
Authority:
Unspecified
Study ID:
CDR0000582623
NCT ID:
NCT00616499
Start Date:
November 2006
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- adenocarcinoma of the lung
- bronchoalveolar cell lung cancer
- large cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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