Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Erlotinib 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 erlotinib works in treating patients with advanced non-small cell lung cancer.

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

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)

• Stage IIIB (malignant pleural or pericardial effusion) disease

• Stage IV disease

• Recurrent and/or medically inoperable disease

• Measurable or evaluable indicator lesions

• No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%

• Life expectancy ≥ 8 weeks

• WBC ≥ 3,000/mm³

• Hemoglobin ≥ 9.0 g/dL

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.0 mg/dL

• AST ≤ 2 times upper limit of normal

• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No significant medical history or unstable medical condition, including any of the following:

• Unstable systemic disease

• Congestive heart failure

• Recent myocardial infarction

• Unstable angina

• Active infection

• Uncontrolled hypertension

• No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior radiation therapy to a major bone marrow-containing area

• At least 3 weeks since prior chemotherapy

• No more than 1 prior chemotherapy regimen for NSCLC

• No prior systemic cytotoxic chemotherapy for other malignant diseases

• No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab [Herceptin®], or gefitinib)

• No concurrent radiotherapy or chemotherapy