Study of Cetuximab in Combination With Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer

NCT00034541 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-04-09

No results posted yet for this study

Summary

The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the duration of the study.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

BIOLOGICAL

cetuximab

400 mg/m2 i.v. over 120 minutes

DRUG

paclitaxel

225 mg/m2, infusion

DRUG

carboplatin

30-minute AUC = 6, infusion.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER
  • Greenwich Hospital

    collaborator OTHER
  • Indiana University

    collaborator OTHER
  • Eli Lilly and Company

    lead INDUSTRY

Principal Investigators

  • E-mail: ClinicalTrials@ ImClone.com · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-31
Primary Completion
2003-05-31
Completion
2003-05-31

Countries

  • United States

Study Locations

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Entities

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 NCT00034541 on ClinicalTrials.gov