The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

Sponsor
Kobe City General Hospital
Study ID
NCT02200354
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 25, 2014
Start date
Jul 31, 2014
Status verified
Aug 2019
Primary completion
Mar 20, 2018
Completion
Mar 20, 2019

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pemetrexed with bevacizumab
    pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1)

Primary Outcome Measure

progression free survival [ Time Frame: Within the study period and until tumor proression, an expected average of 16 weeks ]

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