Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT00227773|
Recruitment Status : Withdrawn
First Posted : September 28, 2005
Last Update Posted : October 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Carcinoid Tumor Islet Cell Carcinoma||Drug: octreotide acetate Drug: vatalanib 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||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227773
|Study Chair:||Kyle Holen, MD||University of Wisconsin, Madison|
|OverallOfficial:||Mary Mulcahy, MD||Robert H. Lurie Cancer Center|