Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

Inclusion Criteria

INCLUSION CRITERIA:

- Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or
adenocarcinoma of the lung with BAC features meeting 1 of the following stage
criteria:

- Stage IIIB disease (with pleural or pericardial effusion)

- Stage IV disease

- Recurrent disease

- Measurable disease

- Tumor tissue available from biopsy

- Age of 18 and over

- ECOG performance status of 0-2

- Life expectancy greater than 3 months

- White blood cell (WBC) ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times
upper limit of normal

- Creatinine normal OR Creatinine clearance ≥ 60 mL/min

- No more than 1 prior chemotherapy regimen for advanced BAC

- More than 3 years since prior chemotherapy for other malignancies

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for
this malignancy and recovered

- HIV-positive patients are eligible provided the following criteria are met:

- CD4 count ≥ 100/mm^3

- Undetectable viral load within the past 3 months

- Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry

- Fertile patients must use effective contraception

- At least 2 weeks since prior radiotherapy and recovered

EXCLUSION CRITERIA:

- Untreated brain metastases

- Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy
to the brain are eligible

- Acute hepatitis

- Symptomatic congestive heart failure

- Uncontrolled hypertension

- Unstable angina pectoris

- Cardiac arrhythmia

- Pregnant or nursing

- Prior allergic reaction to chimerized or murine monoclonal antibody therapy

- Documented presence of human anti-mouse antibodies

- Ongoing or active infection

- Psychiatric illness or social situation that would preclude study compliance

- Other uncontrolled illness

- Prior cetuximab

- Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

- Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or
erlotinib)

- Other concurrent investigational agents

- Other concurrent anticancer therapy