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

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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



- Determine the objective response rate in patients with recurrent or stage IIIB or IV
bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated
with cetuximab.


- Determine the overall survival and time to progression in patients treated with this

- Determine the toxic effects of this drug in these patients.

- Correlate expression of total and phosphorylated epidermal growth factor receptor
(EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with
response in patients treated with this drug.

- Determine whether the presence of polymorphisms or mutations in the EGFR gene
influences response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once on days 1, 8, 15, and 22. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

ACTUAL ACCRUAL: A total of 72 patients were accrued for this study.

Inclusion Criteria


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

- 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


- 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

- Other concurrent investigational agents

- Other concurrent anticancer therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (Proportion of Patients With Objective Response)

Outcome Description:

Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.

Outcome Time Frame:

Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

Safety Issue:


Principal Investigator

Suresh Ramalingam, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Emory Winship Cancer Institute


United States: Federal Government

Study ID:




Start Date:

August 2005

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • bronchioalveolar carcinoma (BAC)
  • adenocarcinoma with BAC features
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • cetuximab
  • Adenocarcinoma
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Lung Neoplasms



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