Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

NCT00097227 | Completed Phase 2

• 1 other identifier: CA225-058
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; non-small; lung; IIIb; IV; Carboplatin; Paclitaxel; Cetuximab; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To estimate median progression free survival and the progression free survival rate

  6 months

Secondary Outcomes (5)

• To estimate the overall response rate in each treatment arm

  6 months

• To estimate median survival and the survival rate at one year in each treatment arm

  6 months

• To evaluate the toxicity profile of each treatment arm

  6 months

• To explore the relationship between EGFR expression and the "clinical benefit" received from each treatment regimen

  6 months

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

  6 months

Study Arms (2)

Arm A (3-week cycle)

ACTIVE COMPARATOR

Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel

Arm B (4-week cycle)

ACTIVE COMPARATOR

Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.

Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Cetuximab BIOLOGICAL

(Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B.

Also known as: Erbitux

Arm A (3-week cycle); Arm B (4-week cycle)

Carboplatin DRUG

(AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.

Also known as: Paraplatin

Arm A (3-week cycle); Arm B (4-week cycle)

Paclitaxel DRUG

225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.

Also known as: Taxol

Arm A (3-week cycle); Arm B (4-week cycle)

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 and have a complete signed informed consent form.
• 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.
• Subjects with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment and be off steroids.
• 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.
• If diagnostic tissue or slides are available for a subject, these must be submitted for testing of EGFR status.
• 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.
• 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 infusion reaction to a monoclonal antibody.
• Subjects with know allergy to Cremophor EL.
• Subjects with known peripheral neuropathy (\> grade 1).
• Subjects with prior erythropoietin (i.e., Epogen, Procrit) treatment.

Sponsors & Collaborators

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

Study Sites (20)

ImClone Investigational Site

Los Angeles, California, 90089, United States

Location

ImClone Investigational Site

Santa Monica, California, 90404, United States

Location

ImClone Investigational Site

Newark, Delaware, 19713, United States

Location

ImClone Investigational Site

Orlando, Florida, 32804, United States

Location

ImClone Investigational Site

St. Petersburg, Florida, 33705, United States

Location

ImClone Investigational Site

Tucker, Georgia, 30084, United States

Location

ImClone Investigational Site

Terra Haute, Indiana, 47804, United States

Location

ImClone Investigational Site

Louisville, Kentucky, 40202, United States

Location

ImClone Investigational Site

Baltimore, Maryland, 21204, United States

Location

ImClone Investigational Site

Ypsilanti, Michigan, 48197, United States

Location

ImClone Investigational Site

Newark, New Jersey, 07112, United States

Location

ImClone Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

ImClone Investigational Site

Philadelphia, Pennsylvania, 19141, United States

Location

ImClone Investigational Site

Columbia, South Carolina, 29209, United States

Location

ImClone Investigational Site

Knoxville, Tennessee, 37920, United States

Location

ImClone Investigational Site

Houston, Texas, 77024, United States

Location

ImClone Investigational Site

Temple, Texas, 76508, United States

Location

ImClone Investigational Site

Richmond, Virginia, 23230, United States

Location

ImClone Investigational Site

Tacoma, Washington, 98405, United States

Location

ImClone Investigational Site

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Carboplatin; Paclitaxel

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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 (20)