Status:
COMPLETED
Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Non-Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lun...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
- 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
- Any histological/cytological evidence of predominantly squamous NSCLC.
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00768755
Start Date
January 1 2009
End Date
March 1 2012
Last Update
October 28 2015
Active Locations (52)
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1
Pfizer Investigational Site
Huntsville, Alabama, United States, 35805
2
Pfizer Investigational Site
Atlanta, Georgia, United States, 30341
3
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
4
Pfizer Investigational Site
Macon, Georgia, United States, 31217