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

Completed · Phase 2

Conditions studied: Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Neoplastic Syndrome

In brief

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.

Key facts

Study ID

NCT00427349

Run by

Eastern Cooperative Oncology Group

People needed

46

Starts

2008-11-07

Expected to finish

2015-04-01

Last updated by the study team

2023-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Center of Kansas, PA - Pratt — Pratt, Kansas, United States
• Cancer Center of Kansas, PA - Salina — Salina, Kansas, United States
• Cancer Center of Kansas, PA - Wellington — Wellington, Kansas, United States
• Associates in Womens Health, PA - North Review — Wichita, Kansas, United States
• Cancer Center of Kansas, PA - Medical Arts Tower — Wichita, Kansas, United States
• Cancer Center of Kansas, PA - Wichita — Wichita, Kansas, United States
• CCOP - Wichita — Wichita, Kansas, United States
• Via Christi Cancer Center at Via Christi Regional Medical Center — Wichita, Kansas, United States
• Cancer Center of Kansas, PA - Winfield — Winfield, Kansas, United States
• Saint Joseph Mercy Cancer Center — Ann Arbor, Michigan, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• Oakwood Cancer Center at Oakwood Hospital and Medical Center — Dearborn, Michigan, United States
• Green Bay Oncology, Limited - Escanaba — Escanaba, Michigan, United States
• Genesys Hurley Cancer Institute — Flint, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• Van Elslander Cancer Center at St. John Hospital and Medical Center — Grosse Pointe Woods, Michigan, United States
• Dickinson County Healthcare System — Iron Mountain, Michigan, United States
• Foote Memorial Hospital — Jackson, Michigan, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• Sparrow Regional Cancer Center — Lansing, Michigan, United States
• St. Mary Mercy Hospital — Livonia, Michigan, United States
• St. Joseph Mercy Oakland — Pontiac, Michigan, United States
• Cancer Center of Kansas, PA - Parsons — Parsons, Kansas, United States

Full record on ClinicalTrials.gov

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