Status:
COMPLETED
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 st...
Detailed Description
OBJECTIVES: Primary * Determine the 4-month progression-free survival (PFS) of patients with low-grade neuroendocrine tumors treated with AMG 706 and octreotide acetate. Secondary * Determine the ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00427349
Start Date
November 7 2008
End Date
April 1 2015
Last Update
July 5 2023
Active Locations (112)
Enter a location and click search to find clinical trials sorted by distance.
1
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, United States, 60402
2
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
3
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
4
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432