Vatalanib and Octreotide in Treating Patients With Progressive 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.
Gastrointestinal Carcinoid Tumor
Islet Cell Carcinoma
Drug: octreotide acetate
Procedure: anti-cytokine therapy
Procedure: antiangiogenesis therapy
Procedure: biological therapy
Procedure: endocrine therapy
Procedure: enzyme inhibitor therapy
Procedure: growth factor antagonist therapy
Procedure: hormone therapy
Procedure: protein tyrosine kinase inhibitor therapy
Procedure: somatostatin analogue therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227773
|Study Chair:||Kyle Holen, MD||University of Wisconsin, Madison|
|Investigator:||Mary Mulcahy, MD||Robert H. Lurie Cancer Center|