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

NCT00097214 | Completed Phase 2

• 1 other identifier: CA225-081
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 8

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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Non-small; Lung; IIIB; IV; Carboplatin; Cetuximab; Stage IIIB non-small cell lung cancer; Stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the overall response rate

  Every six months

Secondary Outcomes (4)

• To evaluate the proportion of subjects with progression free survival (median and 6 months)

  Every six months

• To evaluate survival times (median and 1-year)

  Every six months

• To evaluate the toxicity profiles of the treatment regimen

  Every 12 weeks

• To evaluate symptom response rate using the Lung Cancer Subscale (LCS) of the FACT-L

  Every 12 weeks

Study Arms (1)

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; Biological: Cetuximab

Interventions

Carboplatin DRUG

AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8.

Also known as: Paraplatin

1

Cetuximab BIOLOGICAL

400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8.

Also known as: erbitux

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Bristol-Myers Squibb: collaborator

Study Sites (8)

ImClone Investigational Site

Bentonville, Arkansas, 72712, United States

Location

ImClone Investigational Site

Tucker, Georgia, 30084, United States

Location

ImClone Investigational Site

Evanston, Illinois, 60201, United States

Location

ImClone Investigational Site

Louisville, Kentucky, 40202, United States

Location

ImClone Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

ImClone Investigational Site

Fayetteville, North Carolina, 28309, United States

Location

ImClone Investigational Site

Langhorne, Pennsylvania, 19047, United States

Location

ImClone Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2004
• First Posted: November 19, 2004
• Study Start: November 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: April 9, 2010

Record last verified: 2010-04

Locations

US (8)