The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

Phase 2

Terminated

• Conditions: Advanced Non-small Cell Lung Cancer
• Interventions: Drug: pemetrexed with bevacizumab

• Registration Number: NCT02200354
• Lead Sponsor: Kobe City General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-20
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Primary Completion: 2018-03-20
• Study Completion: 2019-03-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pemetrexed with bevacizumab	pemetrexed with bevacizumab	pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1)

Primary Outcome Measures

Name	Time	Method
progression free survival	Within the study period and until tumor proression, an expected average of 16 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years
response rate	The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks
time to treatment failure (TTF)	From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
overall survival	From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years

Trial Locations

Locations (1)

Kobe City Medical Center General Hospital; 🇯🇵 Kobe, Hyogo, Japan