Phase 2 Trial of Bevacizumab in Combination With Pemetrexed

NCT00227019 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-03-06

Study results available
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Summary

This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while evaluating progression-free survival (PFS) and overall survival (OS).

Conditions

  • Non-small Cell Lung Cancer (NSCLC)
  • Lung Cancer
  • Neoplasm Metastasis

Interventions

DRUG

Bevacizumab

15 mg/kg, IV over 10 minutes every 3 weeks

DRUG

Pemetrexed

500 mg/m²; IV over 10 minutes every 3 weeks

DRUG

Vitamin B12

1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed

DRUG

Folate

350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose

DRUG

Dexamethasone

4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY
  • Genentech, Inc.

    collaborator INDUSTRY
  • Heather Wakelee

    lead OTHER

Principal Investigators

  • Heather A. Wakelee · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00227019 on ClinicalTrials.gov