Gastrointestinal Carcinoid Tumor Clinical Trial
Official title:
Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control
symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide
may be an effective treatment for neuroendocrine tumors.
PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide
works in treating patients with progressive neuroendocrine tumors.
OBJECTIVES:
- 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
unacceptable toxicity.
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
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