The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

Kobe City General Hospital

Status and phase: Terminated; Phase 2

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: pemetrexed with bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02200354

PEM-RE-2014

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

pemetrexed with bevacizumab

Experimental group

Description:

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

Treatment:

Drug: pemetrexed with bevacizumab