The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

NCT ID: NCT02200354

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-03-20

Brief Summary

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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

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Conditions

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Advanced Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pemetrexed with bevacizumab

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

Group Type EXPERIMENTAL

pemetrexed with bevacizumab

Intervention Type DRUG

Interventions

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pemetrexed with bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kobe City General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daichi Fujimoto

doctor, division of respiratory medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daichi Fujimoto, MD

Role: PRINCIPAL_INVESTIGATOR

Kobe City Medical Center General Hospital

Locations

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Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Countries

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Japan

Other Identifiers

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PEM-RE-2014

Identifier Type: -

Identifier Source: org_study_id

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