A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors
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 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
achaetescute homolog-1, 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 vascular
endothelial growth factor (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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Time to progression
No
Kyle D. Holen, MD
Study Chair
University of Wisconsin, Madison
United States: Federal Government
CDR0000526256
NCT00427349
September 2008
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Hinsdale, Illinois 60521 | |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Southwest Medical Center | Liberal, Kansas 67901 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
Bettendorf, Iowa 52722 | |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Hematology Oncology Associates of Illinois - Berwyn | Berwyn, Illinois 60402 |
La Grange Oncology Associates - Geneva | Naperville, Illinois 60563 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |