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A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC

NCT00251524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2012-05-11

No results posted yet for this study

Summary

This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous NSCLC.

Each cycle will be 21 days. Patients will be evaluated every 2 cycles (\~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study.

Patients will receive 6 cycles of Eloxatin, Alimta, and Bevacizumab. After the 6 cycles, patients will receive Bevacizumab alone every 21 days until evidence of disease progression or unacceptable toxicity.

Note: Once patient has completed the 6 cycles of Eloxatin, Alimta, and Bevacizumab and is receiving single-agent Bevacizumab, assessment of response will be performed every 3 cycles (\~every 9 weeks) using RECIST criteria.

Conditions

Interventions

DRUG

Bevacizumab, Oxaliplatin, Pemetrexed

Avastin 15 mg/kg IV, Alimta 500 mg/m2 IV given over 10 minutes, Eloxatin 120 mg/m2 IV given over 2 hours

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Veeda Oncology

    lead OTHER

Principal Investigators

  • John Waples, 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

Start
2005-11-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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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 NCT00251524 on ClinicalTrials.gov