AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Condition: Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Neoplastic Syndrome
MeSH terms: Neoplasms; Neuroendocrine Tumors; Carcinoid Tumor; Malignant Carcinoid Syndrome; Gastrointestinal Neoplasms; Adenoma, Islet Cell
Intervention: AMG 706; octreotide
Intervention description: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment; One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.
Intervention MeSH terms: Octreotide; Motesanib diphosphate; Imetelstat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: localized gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; metastatic gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor; gastrinoma; insulinoma; WDHA syndrome; glucagonoma; pancreatic polypeptide tumor; somatostatinoma; recurrent islet cell carcinoma; neuroendocrine tumor

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.
    

Eligibility 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