RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating patients with relapsed esophageal cancer and/or stomach cancer.
OBJECTIVES: Primary * To determine the disease control rate (complete response, partial response, and stable disease) of sorafenib tosylate after 4 months in patients with relapsed esophageal or gastric adenocarcinoma previously treated with platinum-based chemotherapy. Secondary * To determine the progression-free survival of patients treated with this drug. * To determine the overall survival of patients treated with this drug. * To determine the time to tumor progression in patients treated with this drug. * To determine the objective response rate in patients treated with this drug. * To determine the tolerability and toxicity in patients treated with this drug. * To assess biomarkers associated with response/resistance to therapy. (exploratory) OUTLINE: This is a multicenter study. Patients receive oral sorafenib tosylate twice a day on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Blood and tumor samples may be collected periodically and analyzed for biological markers. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Bon Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Disease control rate after 4 months
Time frame: After 4 months of treatment
Progression-free survival
Progression free survival and overall survival probabilities over time will be estimated using Kaplan-Meier plots. Their medians with their confidence intervals will be also presented. Progression Free Survival is measured from first treatment until the date of disease progression or death, whichever is reported first. Subjects who do not progress or die at the time of the analysis will be censored at the day of their last tumour assessment.
Time frame: Ongoing
Overall survival
Overall survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.
Time frame: Ongoing
Time to tumor progression
Time frame: Ongoing
Objective response rate
The study has been designed to use the disease control rate at 4 months on treatment as the primary endpoint.
Time frame: Response would be assessed by appropriate imaging (e.g. CT) every 8 weeks.
Tolerability and toxicity
Patients would be assessed for toxicity according to NCI CTC version 3.
Time frame: Ongoing for duration of treatment and 30 day follow up.
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St. James's Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
University College Hospital
Galway, Ireland
Waterford Regional Hospital
Waterford, Ireland