Gastric Cancer Clinical Trial
Official title:
Phase II Study of Single Agent Sorafenib in the Treatment of Relapsed Esophageal/Gastric Adenocarcinoma in Platinum Pre-Treated Patients
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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