Conditions: Gastrinoma Glucagonoma Insulinoma Metastatic Gastrointestinal Carcinoid Tumor Neuroendocrine Tumor Pancreatic Polypeptide Tumor Recurrent Gastrointestinal Carcinoid Tumor Recurrent Islet Cell Carcinoma Somatostatinoma WDHA Syndrome
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

Brief summary:
This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. 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.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in patients with advanced neuroendocrine tumors.

SECONDARY OBJECTIVES:

I. Adverse event rate(s). II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival.

OUTLINE: This is a multicenter study. Patients are grouped into 2 separate analysis Groups according to tumor type (Group A: Carcinoid; Group B: Islet cell/other well-differentiated tumor). Each Group was independently evaluated for all study endpoints.

Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.

Arms:
arm 1: Patients receive 400 mg oral sorafenib twice daily on days 1-28. arm 2: Patients receive 400 mg oral sorafenib twice daily on days 1-28.

Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: 400 mg given orally

Protocol document: