Overview

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