Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies
Overview
- Phase
- Phase 2
- Intervention
- immunoenzyme technique
- Conditions
- Lung Cancer
- Sponsor
- Greg Otterson
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: Primary * 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. Secondary * 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. Tertiary Objectives * 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.
Investigators
Greg Otterson
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: immunoenzyme technique
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.
Intervention: carboplatin
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.
Intervention: paclitaxel albumin-stabilized nanoparticle formulation
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.
Intervention: protein expression analysis
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.
Intervention: immunohistochemistry staining method
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.
Time Frame: Up to 5 years
Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary Outcomes
- Overall Survival(Up to 5 years)
- Progression Free Survival(Up to 5 years)
- Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0(Up to 5 years)