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octreotide acetate

vatalanib

anti-cytokine therapy

antiangiogenesis therapy

biological therapy

endocrine therapy

enzyme inhibitor therapy

growth factor antagonist therapy

hormone therapy

protein tyrosine kinase inhibitor therapy

somatostatin analogue therapy

Kyle Holen, MD

Mary Mulcahy, MD

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.

Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors	NCT00227773	Gastrointestina... Islet Cell Carc...	octreotide acet... vatalanib anti-cytokine t... antiangiogenesi... biological ther... endocrine thera... enzyme inhibito... growth factor a... hormone therapy protein tyrosin... somatostatin an...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors	NCT00227773	Gastrointestina... Islet Cell Carc...	octreotide acet... vatalanib anti-cytokine t... antiangiogenesi... biological ther... endocrine thera... enzyme inhibito... growth factor a... hormone therapy protein tyrosin... somatostatin an...	18 Years - 120 Years	Eastern Cooperative Oncology Group

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