Carboplatin Plus Cetuximab for Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT00097214 |
Recruitment Status :
Completed
First Posted : November 19, 2004
Last Update Posted : April 9, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | November 18, 2004 | |||
First Posted Date ICMJE | November 19, 2004 | |||
Last Update Posted Date | April 9, 2010 | |||
Study Start Date ICMJE | November 2004 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To evaluate the overall response rate [ Time Frame: Every six months ] | |||
Original Primary Outcome Measures ICMJE |
To evaluate the overall response rate | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Carboplatin Plus Cetuximab for Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) | |||
Official Title ICMJE | A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer | |||
Brief Summary | This is a phase II study in previously untreated subjects with histologically or cytologically proven stage IIIB/IV NSCLC designed to determine the efficacy of first line treatment with carboplatin and cetuximab. | |||
Detailed Description | Lung cancer is the second most common cancer diagnosed for both genders in the United States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004. Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced disease is limited. The study will test carboplatin in combination with a newly approved drug called cetuximab, which is continuing to be tested in colorectal cancer and other cancers. Cetuximab is a monoclonal antibody, which is believed to work by attaching to an epidermal growth factor receptor (EGFR) on tumor cells and thereby blocking tumor cells from reproducing. It is an antibody to the EGFR. Fifty percent of lung cancers overexpress EGFR. Rationale: The present study is built upon the data from the described studies, incorporating cetuximab into a regimen of single-agent carboplatin. Previous data suggest that single agent carboplatin is active in NSCLC. The addition of biologic therapy with the anti-EGFR agent cetuximab to carboplatin will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIB/IV NSCLC. Research Hypothesis: The population being studied in this trial is subjects with previously untreated Stage IIIB or IV NSCLC. The research hypothesis is that these subjects will achieve a response (based on RECIST criteria) to therapy with the combination of carboplatin and cetuximab. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-small Cell Lung Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1
Cetuximab 400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8. Carboplatin AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8. Therapy will continue for four cycles (12 weeks)for combination therapy Interventions:
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Publications * | Bradford DS, Socinski MA, LaRocca RV, Hensing TA, Bordoni RE. Phase II trial of carboplatin plus cetuximab for the treatment of Stage IIIB/IV non-small cell lung cancer (NSCLC). J Clin Oncol, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 18005. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
57 | |||
Original Enrollment ICMJE |
50 | |||
Actual Study Completion Date ICMJE | April 2007 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | INCLUSION CRITERIA: To be eligible for the study, subjects must fulfill all of the following criteria.
Physical and Laboratory Test Findings
EXCLUSION CRITERIA: Any of the following criteria will make the subject ineligible to participate in this study:
Prohibited Therapies and/or Medications
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00097214 | |||
Other Study ID Numbers ICMJE | CA225-081 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Chief Medical Officer, ImClone LLC | |||
Study Sponsor ICMJE | Eli Lilly and Company | |||
Collaborators ICMJE | Bristol-Myers Squibb | |||
Investigators ICMJE |
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PRS Account | Eli Lilly and Company | |||
Verification Date | April 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |