Overview
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Status:
Completed
Completed
Trial end date:
2015-04-01
2015-04-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Eastern Cooperative Oncology GroupCollaborator:
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