CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Bevacizumab +4 moredrug
Likely dose
Bevacizumab 15 mg/kg IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeksAI-extracted
Key inclusion· 8
  • ✓Advanced stage NSCLC with measurable or evaluable disease, excluding squamous cell histology
  • ✓Stable brain metastases previously treated with radiation or surgery, documented stable on imaging ≥1 month post-treatment, no longer requiring active therapy such as steroids
  • ✓Prior treatment with one standard platinum-containing doublet regimen for NSCLC
  • ✓ECOG performance status 0-1
Key exclusion· 14
  • ✕Prior treatment with pemetrexed or bevacizumab
  • ✕Prior chemotherapy within 28 days (6 weeks for BCNU, CCNU, or mitomycin-C)
  • ✕More than one prior chemotherapy regimen (exceptions: one regimen stopped for toxicity with immediate replacement, or neoadjuvant/adjuvant therapy ≤4 cycles for early-stage disease)
  • ✕Squamous cell carcinoma or histology in close proximity to major vessel or with significant cavitation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00227019
NCT00227019Phase 2Completed
CompareCT.gov

Phase II Trial of Bevacizumab in Combination With Pemetrexed as Second Line Therapy in Patients With Stable Brain Metastases From Non-small Cell Lung Cancer (NSCLC) (Excluding Squamous Cell Carcinoma)

Heather Wakelee·interventional·Posted Sep 27, 2005·Updated Mar 6, 2017

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Pemetrexed, and 3 other interventions for Non-small Cell Lung Cancer (NSCLC) and 2 related conditions. Completed, enrolled 16 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer (NSCLC), Lung Cancer, Neoplasm Metastasis
CountriesUnited States
CollaboratorsEli Lilly and Company, Genentech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2005
Enrollment StartMar 1, 2006
Primary CompletionNov 1, 2010
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 years ago

Interventions

Bevacizumabdrug

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

Pemetrexeddrug

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

Vitamin B12drug

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

Folatedrug

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

Dexamethasonedrug

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