Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) In Patients With Advanced Bronchioloalveolar Cell Lung Cancer
Inclusion Criteria:
- Either bronchioloalveolar cell carcinoma or a variant thereof after review
- Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or
recurrent/medically inoperable disease
- Measurable or evaluable indicator lesions
- No prior or one chemotherapy regimen for NSCLC
- Three weeks since last chemotherapy, and three weeks since prior radiation therapy to
a major bone-marrow containing area
- Karnofsky performance status > or = to 80% OR ECOG performance status ≤ or = to 1
- Life expectancy > or = to 8 weeks
- Adequate hematologic, renal and/or hepatic function: WBC > or = to 3,000/ul,
hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin <
or = to 1.0 mg/dl, AST < than or = to 2.5 X UNL, creatinine < or = to 1.5 mg/dl or
Clcr > or = to 55ml/min.
- Effective contraception
Exclusion Criteria:
- Prior exposure to OSI-774 or other treatments targeting the HER family axis
(e.g.-trastuzumab, ZD1839, C225, etc.)
- Two or more prior chemotherapy regimens
- Concurrent active cancer
- Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is
radiographically unstable, symptomatic and/or requiring escalating doses of
corticosteroids)
- Pregnant or lactating women
- Malignancies within the past 5 years except for adequately treated carcinoma of the
cervix or basal or squamous cell carcinomas of the skin
- Prior systemic cytotoxic chemotherapy for other malignant disease
- Significant medical history or unstable medical condition (unstable systemic disease:
congestive heart failure, recent MI, unstable angina, active infection, uncontrolled
hypertension).