Spots Global Cancer Trial Database for Sorafenib. ICORG 06-41, V4

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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