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

NCT00251498 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2008-08-21

No results posted yet for this study

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

Interventions

DRUG

Cetuximab

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

Sponsors & Collaborators

Principal Investigators

  • Chandra Belani, MD · Veeda Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251498 on ClinicalTrials.gov