AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Recruitment status was Active, not recruiting
RATIONALE: AMG 706 and octreotide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well AMG 706 and octreotide work in treating patients with low-grade neuroendocrine tumors.
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Drug: motesanib diphosphate
Drug: octreotide acetate
Genetic: gene expression analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
Procedure: computed tomography
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors|
- Time to progression [ Designated as safety issue: No ]
- Progression-free survival at 4 months [ Designated as safety issue: No ]
- Objective response (complete or partial response, progressive disease, or stable disease) as measured by RECIST criteria [ Designated as safety issue: No ]
- Toxicity and tolerability [ Designated as safety issue: Yes ]
- Effect of AMG 706 on markers in tumor cells [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
- Determine the 4-month progression-free survival (PFS) of patients with low-grade neuroendocrine tumors treated with AMG 706 and octreotide acetate.
- Determine the response rate and overall survival of patients treated with these drugs.
- Determine the toxicity and tolerability of AMG 706 in these patients.
- Determine the effect of AMG 706 on tumor perfusion by functional CT scan.
- Determine the effect of AMG 706 on tumor markers (e.g., chromogranin A, 5-hydroxyindoleacetic acid, and gastrin) specific for neuroendocrine tumors.
- Determine the effect of AMG 706 on serum vascular endothelial growth factor (VEGF) levels.
- Determine the expression of VEGF, VEGF receptor-2 (VEGFR-2), chromogranin A, human achaetescute homolog-1, and Notch1 markers of neuroendocrine tumors.
OUTLINE: This is a multicenter study.
Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Plasma samples are collected at baseline, periodically during study treatment, and at 4 weeks after the completion of study treatment. Samples are used to determine plasma vascular endothelial growth factor (VEGF) levels. Gene expression of downstream markers of Raf kinase expression (raf, MEK, and ERK) as well as HASH1 and Notch1 are evaluated at baseline. Tumor tissue collected at diagnosis or prior surgery is examined by reverse transcriptase-polymerase chain reaction assay. Contrast CT scans are conducted at baseline, day 2 of course 1, and week 8 to assess tumor perfusion.
After the completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
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|Study Chair:||Kyle D. Holen, MD||University of Wisconsin, Madison|
|Investigator:||Mary Mulcahy, MD||Robert H. Lurie Cancer Center|
|Investigator:||Peter J. O'Dwyer, MD, BCh||Abramson Cancer Center of the University of Pennsylvania|