Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Genetic: protein expression analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies|
- Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria. [ Time Frame: Up to 5 years ]Will be estimated with an exact binomial. Response rate is overall response rate (CR+PR) as defined by RECIST criteria
- Progression Free Survival [ Time Frame: Up to 5 years ]Progression free survival of Abraxane/Carboplatin in bevacizumab in the eligible patients.
- Overall Survival [ Time Frame: Up to 5 years ]Will be analyzed using a Kaplan-Meier methods.
- Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 [ Time Frame: Up to 5 years ]The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics
|Study Start Date:||August 2008|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (nab-paclitaxel, carboplatin)
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.
|Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Genetic: protein expression analysis Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- 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 expression profiles.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729612
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Gregory A. Otterson, MD||Ohio State University Comprehensive Cancer Center|