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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

Interventions

AMG 706
octreotide

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.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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