This phase II trial studies how well sorafenib works with carboplatin and paclitaxel in treating participants with head and neck squamous cell cancer that has spread to other parts of the body or that has come back. Drugs used in chemotherapy, such as sorafenib, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES: I. To evaluate the progression free survival of the combination of sorafenib (BAY 43-9006), carboplatin, and paclitaxel in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN). SECONDARY OBJECTIVES: I. Response rate, toxicity, safety profile, exploratory biomarker data, and overall survival. OUTLINE: Participants receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3 hours on day 1, and sorafenib orally (PO) twice daily (BID) on days 2-19. Treatment repeats every 21 days for up to 6 courses. Starting with course 7, participants receive sorafenib PO daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up between 21-35 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
M D Anderson Cancer Center
Houston, Texas, United States
Objective overall response rate
The rate of response to the treatment will be estimated, and the 95% confidence interval will be calculated.
Time frame: Up to 12 years
Time to progression
Kaplan-Meier estimates of time to progression will be provided. Time to progression will be calculated from the first date of receiving study drug until documented progressive disease. Participants without tumor progression at the time of analysis will be censored at the date of their last tumor assessment. Log-rank test will be applied to test the differences in survivals between levels of prognostic factors.
Time frame: Up to 12 years
Progression-free survival
Kaplan-Meier estimates of progression-free survival will be provided. Progression-free survival will be calculated from the first day of receiving study drug until documented progressive disease or death due to any cause (if death occurs before progression). Log-rank test will be applied to test the differences in survivals between levels of prognostic factors.
Time frame: Up to 12 years
Biomarkers
The following biomarkers may be measured where appropriate, dependent on sample availability: phosphorylated ERK, phosphorylated VEFGR-2, p53 expression, CD31, CD34 and CD105 expression, HIF-1 alpha, HIF-2 alpha, Glut-1, CAIX, VHL and p53 mutational status, methylation status, blood cell RNA expression profiling, protein pattern profiling, Her-2, VEGF, and VEFGR2 expression. Correlation with clinical outcomes will be attempted. The association among various continuous and discrete variables will be assessed first by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot. Correlation among continuous variables will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete variables will be tested by Chi-square or Fisher's exact test.
Time frame: Up to 12 years
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