Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer
Verified date | April 2010 |
Source | ImClone LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | ImClone Investigational Site | Bentonville | Arkansas |
United States | ImClone Investigational Site | Chapel Hill | North Carolina |
United States | ImClone Investigational Site | Evanston | Illinois |
United States | ImClone Investigational Site | Fayetteville | North Carolina |
United States | ImClone Investigational Site | Langhorne | Pennsylvania |
United States | ImClone Investigational Site | Louisville | Kentucky |
United States | ImClone Investigational Site | Philadelphia | Pennsylvania |
United States | ImClone Investigational Site | Tucker | Georgia |
Lead Sponsor | Collaborator |
---|---|
ImClone LLC | Bristol-Myers Squibb |
United States,
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 (J
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the overall response rate | Every six months | No | |
Secondary | To evaluate the proportion of subjects with progression free survival (median and 6 months) | Every six months | No | |
Secondary | To evaluate survival times (median and 1-year) | Every six months | No | |
Secondary | To evaluate the toxicity profiles of the treatment regimen | Every 12 weeks | Yes | |
Secondary | To evaluate symptom response rate using the Lung Cancer Subscale (LCS) of the FACT-L | Every 12 weeks | No |
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