NCT00227019

Phase 2 Trial of Bevacizumab in Combination With Pemetrexed

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Heather Wakelee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Brain metastases are a common complication of advanced non-small-cell lung cancer (NSCLC) both at initial presentation and at the time of disease progression. Patients with brain metastases have often been excluded from large randomized phase III trials due to concerns of poorer survival and impaired ability of drugs to cross the blood-brain barrier. However, as survival has improved, some trials have included such patients, often finding similar benefit to patients with metastatic disease elsewhere. Bevacizumab is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor, has emerged as an important adjunct to platinum-based chemotherapy doublets for use in advanced NSCLC. This drug is normally used as a first line chemotherapy. Pemetrexed is a multi-targeted anti-folate agent,which is approved for use in first-line (with platinum), maintenance, and second-line treatment of advanced nonsquamous NSCLC. Based on the efficacy of pemetrexed as a second line agent and the safety questions surrounding bevacizumab in those with treated brain metastases, a trial was designed to look at the combination of both agents as a second line therapy in NSCLC patients with treated stable brain metastases

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-11-01
• Completion: 2016-12-01
• First posted: 2005-09-27
• Last updated: 2017-03-06
• Results posted: 2017-03-06

Locations

4 sites across 1 country: United States