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

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00103207

Run by

Eastern Cooperative Oncology Group

People needed

72

Starts

2005-10-13

Expected to finish

2012-08-01

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• St. Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus — Boca Raton, Florida, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• Swedish-American Regional Cancer Center — Rockford, Illinois, United States
• Regional Cancer Center at Memorial Medical Center — Springfield, Illinois, United States
• Carle Cancer Center at Carle Foundation Hospital — Urbana, Illinois, United States
• Aurora Presbyterian Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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