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Sponsors and Collaborators: |
ImClone LLC Bristol-Myers Squibb |
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Information provided by: | ImClone LLC |
ClinicalTrials.gov Identifier: | NCT00097214 |
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.
Condition | Intervention | Phase |
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Non-small Cell Lung Cancer |
Drug: Carboplatin Biological: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer |
Enrollment: | 57 |
Study Start Date: | November 2004 |
Study Completion Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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 |
Drug: Carboplatin
AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8.
Biological: Cetuximab
400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
To be eligible for the study, subjects must fulfill all of the following criteria.
Physical and Laboratory Test Findings
Subjects with adequate hematologic function defined as: ANC ≥1,500/mm 3 ; WBC
EXCLUSION CRITERIA:
Any of the following criteria will make the subject ineligible to participate in this study:
Prohibited Therapies and/or Medications
United States, Arkansas | |
Highland Oncology Group | |
Bentonville, Arkansas, United States, 72712 | |
United States, Georgia | |
Georgia Cancer Specialist | |
Tucker, Georgia, United States, 30084 | |
United States, Illinois | |
Evanston Northwestern Healthcare | |
Evanston, Illinois, United States, 60201 | |
United States, Kentucky | |
Kentukiana Cancer Institute | |
Louisville, Kentucky, United States, 40202 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
Carolina Cancer Management | |
Fayetteville, North Carolina, United States, 28309 | |
United States, Pennsylvania | |
Abramson Caner Center, Univ of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
St Mary Medical Center | |
Langhorne, Pennsylvania, United States, 19047 |
Study Chair: | Mark A Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
Responsible Party: | ImClone LLC ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CA225-081 |
Study First Received: | November 18, 2004 |
Last Updated: | August 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00097214 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NSCLC Non-small Lung IIIB IV |
Carboplatin Cetuximab Stage IIIB non-small cell lung cancer Stage IV non-small cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Cetuximab |
Non-small Cell Lung Cancer Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Cetuximab Carboplatin Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |