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Phase II Trial of Nab-Paclitaxel Plus Carboplatin for Advanced NSCLC in Patients at Risk of Bleeding from VEGF-Directed Therapies

Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS291)

Author(s): E. M. Bertino, G. A. Otterson, M. A. Villalona-Calero, S. P. Nana-Sinkam, A. M. Ghany, K. R. Donthireddy, N. F. Abdel Karim, S. Cantrell, G. S. Phillips; The Ohio State University Medical Center, Columbus, OH; The Ohio State University Medical Center and Arthur G. James Cancer Hospital and Solove Research Institute, Columbus, OH; The Ohio State University, Columbus, OH; The Ohio State University Comprehensive Cancer Center, Columbus, OH; Center for Biostatistics, The Ohio State University, Columbus, OH

Abstract:

Background: Non-small cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed. In metastatic NSCLC, a platinum-based doublet remains the standard of care, with the addition of bevacizumab, an antiangiogenic agent, when feasible. Antiangiogenic agents result in improved response rates and survival, but bleeding is a significant potential toxicity. In particular, patients with squamous histology and a history of hemopytsis are excluded from treatment with this agent due to bleeding risk. Nab-paclitaxel, an albumin-bound formulation of paclitaxel, an agent commonly used in NSCLC treatment, was safe and effective in phase I/II studies, producing 16-30% response rates (RR). In a phase II study, combination treatment with nab-paclitaxel and carboplatin demonstrated improved efficacy (47% RR). The objective of this trial is to determine the response rate of nab-paclitaxel with carboplatin in patients who are ineligible for bevacizumab therapy.

Methods: Eligible patients include adults with advanced NSCLC who are ineligible for bevacizumab therapy. These include patients with squamous histology, thrombotic or embolic events within 6 months, history of hemoptysis (controlled, non-life-threatening), cavitary lung lesions, and controlled brain metastases. Appropriate organ function (renal, hepatic and bone marrow) is also required, and significant pre-existing neuropathy is an additional exclusion criterion. Treatment consists of nab-paclitaxel 300 mg/m2 and carboplatin AUC 6 on day 1 of a 21-day cycle for up to six cycles. The trial is designed as a single arm, nonrandomized, two-stage Simon model; the first stage has enrolled 27 patients and the second stage will enroll 36 additional patients. The primary endpoint is response rate by RECIST criteria. Secondary objectives include progression-free and overall survival. Correlative studies include peripheral blood microRNA analysis as a pilot study to evaluate for predictive noninvasive biomarkers of response.

 

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