AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imetelstat; Motesanib diphosphate; Niacinamide; Octreotide

Criteria

Inclusion Criteria:

• Histologically confirmed low-grade neuroendocrine neoplasm

• Measurable disease

• Radiographic evidence of disease progression after any prior systemic therapy, chemoembolization, bland embolization, or observation, defined by either of the following:

• Appearance of a new lesion

• At least 20% increase in the longest diameter of any previously documented lesion or in the sum of the longest diameters of multiple lesions

• Tissue block from original diagnostic or surgical specimen required

• Concurrent stable-dose octreotide acetate required

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Negative pregnancy test

• Fertile patients must use effective contraception

• Must be able to receive a contrast-enhanced CT scan

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 75,000/mm³

• Hemoglobin level ≥ 8.0 g/dL

• Bilirubin ≤ 2.0 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver metastases are present)

• Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit of normal as evaluated by echocardiography or multigated acquisition (MUGA) scan

• No history of uncontrolled hypertension (resting blood pressure > 150/90 mm Hg)

• Antihypertensive medications allowed if patients is stable on their current dose

• One prior systemic chemotherapy regimen for low-grade neuroendocrine neoplasm allowed

• Chemoembolization is not considered systemic chemotherapy

• At least 4 weeks since prior major surgery, chemotherapy, radiation therapy, other systemic therapy, or local liver therapy

Exclusion criteria:

• Prior procedures that would adversely affect intestinal absorption

• Prior anti-vascular endothelial growth factors

• Concurrent chemotherapy or radiation therapy

• History of the following within the past 12 months:

• New York Heart Association class III or IV congestive heart failure

• Unstable angina pectoris

• Myocardial infarction

• Symptomatic cardiac arrhythmia

• Cerebrovascular accident or transient ischemic attack

• Arterial or venous thrombosis

• Known history of allergic reactions to AMG 706 or derivatives or to octreotide acetate injections

• Gastrointestinal tract disease resulting in an inability to take oral medication (i.e., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, bowel obstruction, or inability to swallow tablets)

• Pregnant or nursing

• Small cell lung cancer, medullary thyroid cancer, paraganglioma, or pheochromocytoma

• Requirement for intravenous alimentation