Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies
- To determine the response rate, in terms of overall response rate (complete response
and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and
carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who
are ineligible for treatment with bevacizumab.
- To evaluate safety of this regimen in these patients.
- To describe the overall survival of these patients.
- To describe progression-free survival of these patients.
- To explore, in a pilot fashion, the activity of this regimen using predictive
biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples
and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity.
Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for
correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND
SPARC by immunohistochemistry, and serum miRNA expression profiling.
After completion of study treatment, patients are followed periodically.
Allocation: Non-Randomized, Primary Purpose: Treatment
Response rate as defined by RECIST
Gregory A. Otterson, MD
Ohio State University Comprehensive Cancer Center
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|