Status:
COMPLETED
Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00411047
Start Date
September 1 2005
End Date
December 1 2012
Last Update
May 14 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115