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Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103207
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cetuximab
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 71
Study Start Date: August 2005
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • Determine the overall survival and time to progression in patients treated with this drug.
  • 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.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 9-12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Tumor tissue available from biopsy
  • No untreated brain metastases

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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal
  • No acute hepatitis

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No uncontrolled hypertension
  • No unstable angina pectoris
  • No cardiac arrhythmia

Immunologic

  • 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

Immunologic

  • No prior allergic reaction to chimerized or murine monoclonal antibody therapy
  • No documented presence of human anti-mouse antibodies
  • No ongoing or active infection

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior cetuximab
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • 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

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • No other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib)
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103207

  Show 157 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Investigator: Chandra P. Belani, MD Milton S. Hershey Medical Center
Study Chair: Suresh Ramalingam, MD UPMC Cancer Centers
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000409755, ECOG-E1504
Study First Received: February 7, 2005
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00103207  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
bronchoalveolar cell lung cancer
adenocarcinoma of the lung
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Lung Diseases
Cetuximab
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Recurrence
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009