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Study of Oxaliplatin and Gemcitabine With or Without Bevacizumab to Treat Advanced Non-Small Cell Lung Cancer

NCT00217282 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2008-05-22

No results posted yet for this study

Summary

The combination of oxaliplatin and gemcitabine has proven activity in advanced non-small cell lung cancer (NSCLC). Due to its favorable toxicity profile, this combination is optimal for adding new agents. Bevacizumab is an anti-VEGF monoclonal antibody that has also shown favorable results in advanced NSCLC. This study will add bevacizumab to oxaliplatin and gemcitabine as first line treatment in patients with Stage IIIB and IV NSCLC.

Conditions

Interventions

DRUG

oxaliplatin, gemcitabine, bevacizumab

Gemcitabine 1000mg/m2 IV over 30 minutes, on days 1 and 8 followed by Oxaliplatin 130mg/m2 IV over 2 hours on day 1 followed by Bevacizumab 15 mg/kg IV over 90\* minutes, on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks. Patients will be re-evaluated every 2 cycles. If CR, PR or SD, patients will continue treatment up to four cycles or until progression or unacceptable toxicity. Patients achieving CR, PR, or SD after 4 cycles will continue Bevacizumab maintenance: Bevacizumab 15 mg/kg IV q 3 weeks until relapse/progression

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Mt. Sinai Medical Center, Miami

    lead OTHER

Principal Investigators

  • Rogerio Lilenbaum · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2007-06-30
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00217282 on ClinicalTrials.gov