Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer
NCT ID: NCT00768755
Last Updated: 2015-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
180 participants
INTERVENTIONAL
2009-01-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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I
Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
axitinib
5mg BID po up to max 10mg BID po
II
Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
axitinib
5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy
III
pemetrexed and cisplatin
chemotherapy
Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
IV
Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
axitinib
5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy
V
pemetrexed and cisplatin
chemotherapy
Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
Interventions
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axitinib
5mg BID po up to max 10mg BID po
axitinib
5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy
chemotherapy
Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
axitinib
5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy
chemotherapy
Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
* Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
* Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
* Candidate for primary treatment with cisplatin and pemetrexed
Exclusion Criteria
* Small cell or carcinoid lung cancer patients are also ineligible.
* NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
* Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
* Prior treatment with a VEGF or VEGFR inhibitor.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
Macon, Georgia, United States
Pfizer Investigational Site
Marietta, Georgia, United States
Pfizer Investigational Site
Sandy Springs, Georgia, United States
Pfizer Investigational Site
Bloomington, Illinois, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Hershey, Pennsylvania, United States
Pfizer Investigational Site
West Reading, Pennsylvania, United States
Pfizer Investigational Site
East Providence, Rhode Island, United States
Pfizer Investigational Site
East Providence, Rhode Island, United States
Pfizer Investigational Site
Genova, , Italy
Pfizer Investigational Site
Lido Di Camaiore (LU), , Italy
Pfizer Investigational Site
Orbassano (TO), , Italy
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Lubin, , Poland
Pfizer Investigational Site
Otwock, , Poland
Pfizer Investigational Site
Piła, , Poland
Pfizer Investigational Site
Poznan, , Poland
Pfizer Investigational Site
Poznan, , Poland
Pfizer Investigational Site
Prabuty, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Bacau, Bacău, Romania
Pfizer Investigational Site
Iași, Iaşi, Romania
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Pyatigorsk, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Terrassa, Barcelona, Spain
Pfizer Investigational Site
Castellon, Castellon, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Palma de Mallorca, Palma de Mallorca, Spain
Pfizer Investigational Site
Seville, Sevilla, Spain
Pfizer Investigational Site
Basel, , Switzerland
Pfizer Investigational Site
Basel, , Switzerland
Pfizer Investigational Site
Bruderholz, , Switzerland
Pfizer Investigational Site
Liestal, , Switzerland
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Dnipropetrovsk, , Ukraine
Pfizer Investigational Site
Kyiv, , Ukraine
Pfizer Investigational Site
Romford, Essex, United Kingdom
Pfizer Investigational Site
Northwood, Middlesex, United Kingdom
Pfizer Investigational Site
Bournemouth, , United Kingdom
Pfizer Investigational Site
Brighton, , United Kingdom
Pfizer Investigational Site
Dundee, , United Kingdom
Pfizer Investigational Site
Middlesex, , United Kingdom
Pfizer Investigational Site
Poole, , United Kingdom
Countries
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References
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Belani CP, Yamamoto N, Bondarenko IM, Poltoratskiy A, Novello S, Tang J, Bycott P, Niethammer AG, Ingrosso A, Kim S, Scagliotti GV. Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. BMC Cancer. 2014 Apr 25;14:290. doi: 10.1186/1471-2407-14-290.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4061039
Identifier Type: -
Identifier Source: org_study_id
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