The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab
Conditions
Advanced Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: pemetrexed with bevacizumab
Type: Drug
Overall Status
Not yet recruiting
Summary
For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- 20 Years and older

- PS0-2

- Advanced non-squamous non-small cell lung cancer; AND

- Patients who have received more than 4 cycles of pemetrexed therapy before the study

Exclusion Criteria:

- Interstitial pneumonia; AND

- Abnormal blood test
Location
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan
Status: Not yet recruiting
Contact: Daichi Fujimoto, MD - +81-78-302-4321 - daichianzen@yahoo.co.jp
Start Date
July 2014
Sponsors
Kobe City General Hospital
Source
Kobe City General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page