Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
|ClinicalTrials.gov Identifier: NCT00103207|
Recruitment Status : Completed
First Posted : February 8, 2005
Results First Posted : January 4, 2013
Last Update Posted : January 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: cetuximab||Phase 2|
- Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated with cetuximab.
- Determine the overall survival and time to progression in patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
- Correlate expression of total and phosphorylated epidermal growth factor receptor (EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with response in patients treated with this drug.
- Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours once on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
ACTUAL ACCRUAL: A total of 72 patients were accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features|
|Study Start Date :||August 2005|
|Primary Completion Date :||April 2010|
|Study Completion Date :||August 2012|
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.
Other Name: C225
- Objective Response Rate (Proportion of Patients With Objective Response) [ Time Frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ]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.
- Overall Survival [ Time Frame: Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ]Overall survival is defined as the time from registration to death.
- Time to Progression [ Time Frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ]Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.
- Overall Survival by Smoking Status [ Time Frame: Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ]Medians of overall survival by smoking status are reported.
- Time to Progression by Smoking Status [ Time Frame: Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ]Medians of time to progression by smoking status are reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103207
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|Study Chair:||Suresh Ramalingam, MD||Emory Winship Cancer Institute|