RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer	Drug: erlotinib  Procedure: conventional surgery  Procedure: enzyme inhibitor therapy  Procedure: neoadjuvant therapy  Procedure: protein tyrosine kinase inhibitor therapy  Procedure: surgery	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the biochemical response rate, in terms of a decrease of more than 75% in MAP kinase protein and/or AKT-1 protein, in patients with early-stage operable non-small cell lung cancer treated with neoadjuvant erlotinib.

Secondary

• Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity.

Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21).

Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician.

Patients are followed for 5 years after study registration.

PROJECTED ACCRUAL: A total of 55-110 patients will be accrued for this study within 11-22 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• Meets 1 of the following stage criteria:
• Stage IA (T1, N0, M0)
• Stage IB (T2, N0, M0)
• Stage IIA (T1, N1, M0)
• Stage IIB (T2, N1, M0 or T3, N0-1, M0)
• Stage IIIA (T1-3, N2, M0)
• Surgical candidate with resectable disease
• No small-cell component
• Paraffin-embedded cell block and 1-2 segments of frozen tissue demonstrating NSCLC available

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• WBC ≥ 3,500/mm^3

Hepatic

• SGPT and SGOT < 3 times upper limit of normal
• Bilirubin < 1.5 mg/dL

Renal

• Creatinine < 2 mg/dL OR
• Creatinine clearance ≥ 20 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Able to take oral medication
• No malabsorption syndrome
• No known hypersensitivity to erlotinib
• No serious underlying medical condition that would preclude study participation
• No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent myeloid growth factors

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics
• No prior gastrointestinal surgery that would limit absorption (i.e., requires total parental nutrition)

Other

• At least 2 weeks since prior CYP3A4 enzyme-inducing agents
• More than 21 days since prior investigational drugs
• No prior anti-epidermal growth factor receptor therapy
• No concurrent anticoagulation therapy
• No concurrent CYP3A4 enzyme-inducing agents, including the following:
• Phenytoin
• Carbamazepine
• Barbiturates
• Rifampin
• Phenobarbital
• Oxcarbazepine
• Rifapentine
• Hypericum perforatum (St. John's wort)

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting
New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15236,  United States; Recruiting
Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6307,  United States; Recruiting
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States; Recruiting

Study chairs or principal investigators

Steven M. Keller, MD,  Study Chair,  Montefiore Medical Center   
Roman Perez-Soler, MD,  Montefiore Medical Center   

Study ID Numbers:  CDR0000373871; ECOG-E4503; NCT00087269
Record last reviewed:  December 2004
Last Updated:  March 10, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087269
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08