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CompletedPhase 2NCT00124618
Official study title

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

Study 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 carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcetuximab and radiation therapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 6, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?175 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Biological: cetuximab; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→
Treatment approach
Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic ScottsdaleScottsdale, Arizona
  • Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida
  • Mayo Clinic - JacksonvilleJacksonville, Florida
  • Rush-Copley Cancer Care CenterAurora, Illinois
  • Graham HospitalCanton, Illinois
  • Memorial HospitalCarthage, Illinois
  • St. Anthony's Memorial HospitalEffingham, Illinois
  • Eureka Community HospitalEureka, Illinois
  • Galesburg Clinic, PCGalesburg, Illinois
  • Galesburg Cottage HospitalGalesburg, Illinois
  • InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois
  • Mason District HospitalHavana, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2016. Always confirm current availability with the study team.

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