The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02200354
• Other study ID #: PEM-RE-2014
• Status: Terminated
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: March 20, 2019

Study information

• Verified date: August 2019
• Source: Kobe City General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• pemetrexed with bevacizumab

Locations

Country	Name	City	State
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe City General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		Within the study period and until tumor proression, an expected average of 16 weeks
Secondary	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
Secondary	overall survival		From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years
Secondary	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
Secondary	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