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Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

2014-08-27 03:54:40 | BioPortfolio

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with progressive metastatic neuroendocrine tumors.

Description

OBJECTIVES:

Primary

- Determine the 6-month progression-free survival rate in patients with progressive metastatic neuroendocrine tumors treated with gefitinib.

Secondary

- Determine the objective tumor response rate in patients treated with this drug.

- Determine time to progression and progression-free and overall survival in patients treated with this drug.

- Determine improvement in circulating hormone levels in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type (carcinoid vs islet cell and other neuroendocrine tumors).

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

Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.

PROJECTED ACCRUAL: A total of 34-90 patients (22-51 for carcinoid stratum and 12-39 for islet cell/other neuroendocrine tumor stratum) will be accrued for this study within 9 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Gastrointestinal Carcinoid Tumor

Intervention

gefitinib

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:40-0400

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