Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
- Determine the 4-month progression-free and overall survival of patients with
progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide.
- Determine the response rate in patients treated with this regimen.
- Determine the effect of this regimen on tumor markers (e.g., chromogranin A, 5-HIAA,
and gastrin) in these patients.
- Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral vatalanib once daily on days 1- 28 and octreotide* intramuscularly or
IV on day 1. Courses repeat every 28 days in the absence of disease progression or
NOTE: *Patients on a stable dose (i.e., no changes in dosage within the past 3 months) of
octreotide before study entry remain on their current dose and schedule during study
participation; patients who experience hypersensitivity and/or toxicity to octreotide may
receive vatalanib alone.
After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2
years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 3 years.
Primary Purpose: Treatment
Kyle Holen, MD
University of Wisconsin, Madison
United States: Federal Government