The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

NCT02200354 | Terminated Phase 2

• 1 other identifier: PEM-RE-2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Within the study period and until tumor proression, an expected average of 16 weeks

Secondary Outcomes (4)

• 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

• overall survival

  From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years

• 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

• 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

Study Arms (1)

pemetrexed with bevacizumab

EXPERIMENTAL

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

Drug: pemetrexed with bevacizumab

Interventions

pemetrexed with bevacizumab DRUG

pemetrexed with bevacizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Interstitial pneumonia; AND
• Abnormal blood test

Sponsors & Collaborators

• Kobe City General Hospital: lead

Study Sites (1)

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0046, Japan

Location

MeSH Terms

Interventions

Pemetrexed; Bevacizumab

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Daichi Fujimoto, MD

  Kobe City Medical Center General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor, division of respiratory medicine

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 2014
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

JP (1)