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Status:

COMPLETED

Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 c...

Detailed Description

OBJECTIVES: Primary \* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radio...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IIIA or IIIB disease
  • Must be a candidate for curative radiotherapy
  • Not a candidate for other concurrent chemotherapy and radiotherapy
  • No surgical treatment available
  • No pleural effusion suspected or proven to be malignant
  • No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days
  • PATIENT CHARACTERISTICS:
  • Age \* 18 and over
  • Performance status
  • Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
  • ECOG 2 (age 18 to 64 years)
  • Life expectancy
  • \* At least 12 weeks
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Hepatic
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Pulmonary
  • FEV\_1 ≥ 1 L
  • No idiopathic pulmonary fibrosis
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Magnesium normal
  • No uncontrolled infection
  • No other severe underlying disease that would preclude study entry
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
  • No major psychiatric illness that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • \* Not specified
  • Chemotherapy
  • See Disease Characteristics
  • No prior chemotherapy for NSCLC
  • Endocrine therapy
  • \* Not specified
  • Radiotherapy
  • No prior therapeutic radiotherapy to the chest
  • No concurrent intensity modulated radiotherapy
  • Other
  • \* No prior epidermal growth factor receptor inhibitors

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2015

    Estimated Enrollment :

    58 Patients enrolled

    Trial Details

    Trial ID

    NCT00124618

    Start Date

    January 1 2006

    End Date

    March 1 2015

    Last Update

    July 6 2016

    Active Locations (175)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 44 (175 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, United States, 33021

    3

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    4

    Rush-Copley Cancer Care Center

    Aurora, Illinois, United States, 60507