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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

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Suresh Ramalingam, MD
Facilities
  • Morton Hospital - Completed
Trial Interventions
Biological
  • cetuximab
Physician Researcher

Investigator Name:

  • Suresh Ramalingam, MD

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 2
Trial ID: NCT00103207
Volunteers:  Not Accepting Healthy Volunteers

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