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

August 20, 2008 updated by: Veeda Oncology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase II, open label, non-randomized study in patients with histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC who have not received prior chemotherapy. The trial will evaluate the efficacy and safety profile of the combination of docetaxel, carboplatin and cetuximab for patients with advanced NSCLC.

Patients will receive a combination of docetaxel and carboplatin administered every 3 weeks plus cetuximab given weekly. A maximum of four cycles of chemotherapy will be administered to patients. Patients who demonstrate an ongoing response (CR/PR/SD) at the end of 4th cycle of chemotherapy, may receive two more cycles of treatment. Patients who continue to respond (CR/PR/SD) after six cycles of therapy may receive therapy with single agent cetuximab (250 mg/m2/week) for up to 1 year or until disease progression or unacceptable toxicity, whichever occurs first.

Patients will be evaluated for response, time to progression, and overall survival. In addition, the safety profile of the combination will be assessed.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77042
        • Veeda Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veeda Oncology

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Chandra Belani, MD, Veeda Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 10, 2005

Study Record Updates

Last Update Posted (Estimate)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-04-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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