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The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

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ClinicalTrials.gov Identifier: NCT02200354
Recruitment Status : Terminated (inclusion speed)
First Posted : July 25, 2014
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Daichi Fujimoto, 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.

Condition or disease Intervention/treatment Phase
Advanced Non-small Cell Lung Cancer Drug: pemetrexed with bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Study Start Date : July 2014
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pemetrexed with bevacizumab
pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1)
Drug: pemetrexed with bevacizumab



Primary Outcome Measures :
  1. progression free survival [ Time Frame: Within the study period and until tumor proression, an expected average of 16 weeks ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks ]
  2. overall survival [ Time Frame: From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years ]
  3. time to treatment failure (TTF) [ Time Frame: 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 ]
  4. Number of Participants with Adverse Events [ Time Frame: 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200354


Locations
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Japan
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0046
Sponsors and Collaborators
Kobe City General Hospital
Investigators
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Principal Investigator: Daichi Fujimoto, MD Kobe City Medical Center General Hospital
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Responsible Party: Daichi Fujimoto, doctor, division of respiratory medicine, Kobe City General Hospital
ClinicalTrials.gov Identifier: NCT02200354    
Other Study ID Numbers: PEM-RE-2014
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Pemetrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors