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Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC

NCT00621049 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2015-06-08

Study results available
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Summary

Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.

Conditions

Interventions

DRUG

Docetaxel/Carboplatin/Bevacizumab/Erlotinib

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.

DRUG

Docetaxel/Carboplatin

Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • David Spigel, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2013-07-31
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT00621049 on ClinicalTrials.gov