Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

NCT00251498 | Completed Phase 2

• 1 other identifier: I-04-002
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the efficacy (response rate) of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced non-small cell lung cancer. The secondary objectives of this study are:

• to determine the time to progression and overall survival for patients with advanced NSCLC who are treated with the combination docetaxel, carboplatin , and cetuximab
• to determine the toxicity of the combination in patients with advanced NSCLC. Patients with stages IIIB (pleural or pericardial effusion) and IV NSCLC who have not received any prior chemotherapy will be eligible to participate in the trial. Other eligibility criteria include: ECOG PS 0-1, normal hepatic and renal function, age \>18 years. Specific inclusion and exclusion criteria are detailed in Sections 4.2 and 4.3.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Metastatic 1st line NSCLC

Interventions

Cetuximab DRUG

Cycle 1:400 mg/m2, administered as a 120-minute iv infusion on Day 1 and 250 mg/m2 administered as a 60-minute iv infusion on Days 8 and 15, subsequent cycles:250 mg/m2 administered as a 60-minute iv infusion on Days 1, 8, 15

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC.
• Age \> 18 years.
• ECOG PS 0-1.
• No prior chemotherapy for NSCLC.
• Measurable disease by RECIST criteria.
• Signed IRB-approved informed consent.
• Adequate bone marrow function defined by: peripheral absolute neutrophil count (ANC) \>1500/microL, hemoglobin \>9.0 g/dL, and platelet count \>100,000/microL.
• Adequate renal function as defined by serum creatinine level less than institutional upper limit of normal (ULN) or calculated/measured creatinine clearance \> 65 mL/min.
• Adequate liver function defined as: serum total bilirubin \<ULN, serum aspartate aminotransferase (AST) \<2.5 times ULN.
• Estimated life expectancy \>12 weeks.

You may not qualify if:

• Untreated clinically active brain metastasis.
• Radiotherapy within 2 weeks prior to registration or previous irradiation to the only area of measurable disease.
• Treatment with any investigational therapy within 4 weeks prior to registration.
• Prior therapy with an agent that is known to specifically and directly target the EGFR pathway.
• History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
• Patients in their reproductive age group should consent to use an effective method of birth control while on treatment and for at least 3 months thereafter. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study.
• Major surgery within 3 weeks prior to registration.
• Use of immunosuppressive agents including systemic corticosteroids within 4 weeks prior to registration (corticosteroids are permitted as physiological replacement therapy or as supportive care for nausea and emesis).
• Known history of human immunodeficiency virus infection.
• Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator.
• Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
• Concurrent serious infection.
• History of known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80.
• History of prior severe infusion reaction to a monoclonal antibody.
• Patient has \>Grade 2 peripheral neuropathy within 14 days prior to registration

Sponsors & Collaborators

• Veeda Oncology: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Veeda Oncology

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chandra Belani, MD

  Veeda Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 10, 2005
• Study Completion: October 1, 2007
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

US (1)