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CompletedPhase 2NCT00103207
Official study title

Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV 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. PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcetuximab

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 28, 2023 · 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?157 U.S. locations

Locations may change over time.

Who runs it?Eastern Cooperative Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eastern Cooperative Oncology Group
Interventions being studied
Biological: cetuximab
02
Explore related studies

How this study is categorized

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

Disease setting
Metastatic or stage IV→Recurrent or relapsed→
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
  • 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
Reasons someone may not be able to joinExclusion 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

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

  • Aurora Presbyterian HospitalAurora, Colorado
  • Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado
  • St. Anthony Central HospitalDenver, Colorado
  • Porter Adventist HospitalDenver, Colorado
  • Presbyterian - St. Luke's Medical CenterDenver, Colorado
  • St. Joseph HospitalDenver, Colorado
  • Rose Medical CenterDenver, Colorado
  • CCOP - Colorado Cancer Research ProgramDenver, Colorado
  • Swedish Medical CenterEnglewood, Colorado
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado
  • North Colorado Medical CenterGreeley, Colorado
  • Sky Ridge Medical CenterLone Tree, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 28, 2023. Always confirm current availability with the study team.

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