Carboplatin Plus Cetuximab for Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Tracking Information
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; (submitted: November 17, 2008)	To evaluate the overall response rate [ Time Frame: Every six months ]
Original Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	To evaluate the overall response rate
Change History	Complete list of historical versions of study NCT00097214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 17, 2008)	To evaluate the proportion of subjects with progression free survival (median and 6 months) [ Time Frame: Every six months ]; To evaluate survival times (median and 1-year) [ Time Frame: Every six months ]; To evaluate the toxicity profiles of the treatment regimen [ Time Frame: Every 12 weeks ]; To evaluate symptom response rate using the Lung Cancer Subscale (LCS) of the FACT-L [ Time Frame: Every 12 weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: June 23, 2005)	To evaluate the proportion of subjects with progression free survival (median and 6 months); To evaluate survival times (median and 1-year); To evaluate the toxicity profiles of the treatment regimen; To evaluate symptom response rate using the Lung Cancer Subscale (LCS) of the FACT-L
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Non-small Cell Lung Cancer
Intervention ICMJE	Drug: Carboplatin AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8. Other Name: Paraplatin; Biological: Cetuximab 400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8. Other Name: erbitux
Study Arms	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: Drug: Carboplatin; Biological: Cetuximab
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 17, 2008)	57
Original Enrollment ICMJE; (submitted: June 23, 2005)	50
Actual Study Completion Date	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.; Subjects must have signed an approved informed consent.; Subjects with histologically or cytologically documented stage IIIB (supraclavicular lymph node, high neck node, or pleural effusion involvement) or IV NSCLC. Disease must be newly diagnosed or recurrent at least 1 year post adjuvant therapy.; Subjects with measurable disease.; Subjects with ECOG performance status 0-1.; If diagnostic tissue or slides are available for a subject, these must be submitted for testing of EGFR status.; Subjects with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment. Radiotherapy must have been completed >2 weeks prior to enrollment and the subject must have recovered from all adverse effects of prior radiotherapy. No previous irradiation to the only area of measurable disease. New lesions that developed in a previously irradiated area will be allowed.; Subjects ≥18 years of age.; Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35mIU/mL]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication. Physical and Laboratory Test Findings; Subjects with adequate hematologic function defined as: ANC ≥1,500/mm 3 ; WBC ≥3,000/mm 3 ; platelets ≥100,000/mm 3 ; and hemoglobin ≥9 g/dL.; Subjects with adequate hepatic function defined as: total bilirubin ≤1.5 x upper limit of normal (ULN) or AST ≤2.5 x ULN.; Subjects with adequate renal function defined as a serum creatinine level ≤1.5 mg/dL or a creatinine clearance ≥60 cc/minute. EXCLUSION CRITERIA: Any of the following criteria will make the subject ineligible to participate in this study: WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception.; WOCBP using a prohibited contraceptive method.; Women who are pregnant or breastfeeding; Women with a positive pregnancy test on enrollment or prior to study drug administration.; Subjects who have had prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.; Subjects with significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction, myocardial infarction within the past year, or cardiac ventricular arrythmias requiring medication.; Subjects with an uncontrolled seizure disorder, or active neurological disease.; Subjects with symptomatic brain metastasis. Prohibited Therapies and/or Medications; Subjects who have received prior systemic chemotherapy. Subjects with no more than one prior adjuvant regimen for initially diagnosed disease are eligible for the study.; Subjects with a history of prior cetuximab or other therapy that specifically and directly targets the EGFR pathway.; Subject with prior severe reaction to a monoclonal antibody.; Subjects with prior erythropoietin (i.e., Epogen, Procrit) treatment; Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Chief Medical Officer, ImClone LLC
Study Sponsor ICMJE	ImClone LLC
Collaborators ICMJE	Bristol-Myers Squibb
Investigators ICMJE	Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
PRS Account	ImClone LLC
Verification Date	April 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP