Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy

NCT00998101 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-03-06

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.

Conditions

Interventions

DRUG

cetuximab

400 mg/m2 Cycle 1 day 1 only over 120 minutes 250 mg/m2 Cycle 1 days 8,15 AND on all other cycles days 1,8,15 over 60 minutes

DRUG

carboplatin

AUC=6 Day 1 of treatment over 30 minutes every 21 days

DRUG

ixabepilone

30 mg/m2 , Day 1 over 3 hours every 21 days

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Thomas E. Stinchcombe, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

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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 NCT00998101 on ClinicalTrials.gov