Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed non-small cell lung cancer (NSCLC)

• No squamous cell histology

• Stage IIIB (with pleural effusion) or stage IV disease

• Must meet ≥ 1 of the following criteria:

• Female

• Adenocarcinoma tumor histology

• No history of smoking, defined as smoking < 100 cigarettes (5 standard packs of cigarettes) in a lifetime, < 20 oz of pipe tobacco in a lifetime, OR < 100 cigars in a lifetime

• Asian/Pacific Rim ethnicity, defined as Japanese, Chinese, Korean, or other Asian/Pacific Rim ethnicity

• Must have activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene

• Measurable disease

• No symptomatic or newly diagnosed CNS metastases that have not been definitively treated with radiotherapy and/or surgery

• History of CNS metastases or cord compression allowed if definitively treated and clinically stable

PATIENT CHARACTERISTICS:

• See Disease Characteristics

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• Absolute neutrophil count ≥ 2,000/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.25 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN (5 times ULN if liver has tumor involvement)

• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known severe hypersensitivity to gefitinib or any other component of gefitinib tablets

• No evidence of clinically active interstitial lung disease

• Patients with chronic, stable radiographic changes who are asymptomatic are eligible

• No other concurrent malignancy or malignancy diagnosed within the past 5 years except for basal cell carcinoma of the skin or cervical cancer in situ

• No concurrent severe or uncontrolled systemic disorder

• No evidence of any other significant clinical disorder or laboratory finding that, in the opinion of the investigator, would preclude study participation

• Able to tolerate protocol treatment, in the opinion of the investigator

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic chemotherapy, biological therapy, immunotherapy, or hormonal therapy for NSCLC, including adjuvant and neoadjuvant treatment

• No prior radiotherapy to the target lesion

• Prior radiotherapy to bony disease or CNS disease allowed

• At least 2 weeks since prior radiotherapy and recovered

• More than 30 days since prior non-FDA approved or investigational agents

• No prior EGFR antagonists

• At least 2 weeks since prior and no concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort)

• No concurrent chemotherapy, immunotherapy, hormonal therapy, nonpalliative radiotherapy, surgery for cancer, or other experimental medications

• No other concurrent specific antitumor therapy