Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

Neuroendocrine Tumor Clinical Trial

Official title: A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Islet Cell
• Gastrinoma
• Gastrointestinal Neoplasms
• Glucagonoma
• Insulinoma
• Malignant Carcinoid Syndrome
• Metastatic Gastrointestinal Carcinoid Tumor
• Neoplasms
• Neuroendocrine Tumor
• Neuroendocrine Tumors
• Pancreatic Polypeptide Tumor
• Recurrent Gastrointestinal Carcinoid Tumor
• Recurrent Islet Cell Carcinoma
• Somatostatinoma
• Vipoma
• WDHA Syndrome

• NCT number: NCT00131911
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Completion date: April 2013