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Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00103207
First received: February 7, 2005
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  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
 Biological: cetuximab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Objective Response Rate (Proportion of Patients With Objective Response) [ 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from registration to death.

  • Time to Progression [ 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 ] [ Designated as safety issue: No ]
    Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

  • Overall Survival by Smoking Status [ Time Frame: Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ] [ Designated as safety issue: No ]
    Medians of overall survival by smoking status are reported.

  • Time to Progression by Smoking Status [ Time Frame: Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ] [ Designated as safety issue: No ]
    Medians of time to progression by smoking status are reported.


Enrollment: 72
Study Start Date: August 2005
Study Completion Date: August 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
 Biological: cetuximab
Other Name: C225

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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
National Cancer Institute (NCI)
Investigators
Study Chair: Suresh Ramalingam, MD Emory Winship Cancer Institute
  More Information

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

Publications:

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00103207     History of Changes
Other Study ID Numbers: CDR0000409755, U10CA021115, E1504
Study First Received: February 7, 2005
Results First Received: December 3, 2012
Last Updated: December 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
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

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013