AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Neoplastic Syndrome
About this trial
This is an interventional treatment trial for Gastrointestinal Carcinoid Tumor focused on measuring 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
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
Sites / Locations
- Hematology Oncology Associates of Illinois - Berwyn
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Midwest Center for Hematology/Oncology
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- La Grange Oncology Associates - Geneva
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Hematology Oncology Associates - Skokie
- McFarland Clinic, PC
- Hematology & Oncology Care
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Case Comprehensive Cancer Center
- St. Rita's Medical Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- Joan Karnell Cancer Center at Pennsylvania Hospital
- Fox Chase Cancer Center - Philadelphia
- UPMC Cancer Centers
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Arms of the Study
Arm 1
Experimental
AMG 706+Octreotide
Patients receive oral AMG 706 and octreotide acetate intramuscularly (IM) once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. 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 morning. 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.