Clinical trial · Interventional
Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
NCT00103207CI-TRIAL-00067629completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- description
- 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.
- interventionNames
- Biological: cetuximab
Primary outcomes (1)
- measure
- Objective Response Rate (Proportion of Patients With Objective Response)
- timeFrame
- Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTRamalingam SS, Lee JW, Belani CP, Aisner SC, Kolesar J, Howe C, Velasco MR, Schiller JH. Cetuximab for the treatment of advanced bronchioloalveolar carcinoma (BAC): an Eastern Cooperative Oncology Group phase II study (ECOG 1504). J Clin Oncol. 2011 May 1;29(13):1709-14. doi: 10.1200/JCO.2010.33.4094. Epub 2011 Mar 21. PMID 21422434