Spots Global Cancer Trial Database for AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
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Trial Identification
Brief Title: AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Official Title: A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors
Study ID: NCT00427349
Study Description
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 studying how well AMG 706 and octreotide work in treating patients with low-grade neuroendocrine tumors.
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 response rate and overall survival of patients treated with these drugs. * Determine the toxicity and tolerability of AMG 706 in these patients. * Determine the effect of AMG 706 on tumor perfusion by functional computerized tomography (CT) scan. * Determine the effect of AMG 706 on tumor markers (e.g., chromogranin A, 5-hydroxyindoleacetic acid, and gastrin) specific for neuroendocrine tumors. * Determine the effect of AMG 706 on serum vascular endothelial growth factor (VEGF) levels. * Determine the expression of VEGF, VEGF receptor-2 (VEGFR-2), chromogranin A, human achaete-scute homolog-1 (hASH1), and Notch1 markers of neuroendocrine tumors. OUTLINE: This is a multicenter study. Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Plasma samples are collected at baseline, periodically during study treatment, and at 4 weeks after the completion of study treatment. Samples are used to determine plasma VEGF levels. Gene expression of downstream markers of Raf kinase expression (raf, MEK, and ERK) as well as hASH1 and Notch1 are evaluated at baseline. Tumor tissue collected at diagnosis or prior surgery is examined by reverse transcriptase-polymerase chain reaction assay. Contrast CT scans are conducted at baseline, day 2 of course 1, and week 8 to assess tumor perfusion. After the completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hematology Oncology Associates of Illinois - Berwyn, Berwyn, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Midwest Center for Hematology/Oncology, Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States
La Grange Oncology Associates - Geneva, Naperville, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois, United States
McFarland Clinic, PC, Ames, Iowa, United States
Hematology & Oncology Care, Bettendorf, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, Clive, Iowa, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
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
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
St. Rita's Medical Center, Lima, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau, Wisconsin, United States
Contact Details
Name: Mary Mulcahy, MD
Affiliation: Robert H. Lurie Cancer Center
Role: STUDY_CHAIR
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