500 Boylston Street, Boston, MA 02116 617-419-4700
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RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
advanced primary non-small cell lung cancer.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria: - Selected stage IIIB disease (excluding Pancoast tumors) - T4 lesion due to malignant pleural effusion only - Any N - M0 - Stage IV disease - Any T - Any N - M1 - Recurrent disease after prior surgery and/or radiotherapy - The following histologies are eligible: - Adenocarcinoma - Large cell carcinoma - Squamous cell carcinoma - Unspecified - Measurable disease by CT scan, MRI, x-ray, or physical or nuclear exam - Measurable disease must be outside prior irradiated fields OR a new lesion must be present - Measurable disease must be outside the area of prior surgical resection - No brain metastases - Negative CT scan or MRI if there are neurological abnormalities on physical exam or symptoms - Patients must be offered participation in protocol SWOG-S9925 (Lung Cancer Specimen Repository study) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin ≤ upper limit of normal (ULN) AND 1 of the following: - Alkaline phosphatase ≤ ULN AND SGOT OR SGPT ≤ 2 times ULN - Alkaline phosphatase ≤ 4 times ULN AND SGOT OR SGPT ≤ ULN Renal - Creatinine ≤ 2 mg/dL Cardiovascular - No significant history of cardiac disease - No uncontrolled high blood pressure - No unstable angina - No congestive heart failure - No cardiac ventricular arrhythmias requiring medication - No myocardial infarction within the past 6 months Gastrointestinal - No GI tract disease resulting in an inability to take oral medication - No malabsorption syndrome - No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) - No requirement for IV alimentation Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy for NSCLC - No concurrent biologic therapy Chemotherapy - No prior systemic chemotherapy for NSCLC Endocrine therapy - No prior hormonal therapy for NSCLC - No concurrent hormonal therapy Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No concurrent radiotherapy to measurable or non-measurable lesions - Concurrent palliative radiotherapy to small-field non-measurable sites of painful bony metastases allowed provided there are other sites of measurable disease outside of the radiotherapy treatment field Surgery - See Disease Characteristics - At least 3 weeks since prior thoracic or other major surgeries and recovered - No prior surgical procedures affecting gastrointestinal (GI) absorption Other - No prior epidermal growth factor receptor inhibitors
Sponsor: National Cancer Institute (NCI)
Phase: Phase 2
Trial ID: NCT00087412
Not Accepting Healthy Volunteers