AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00427349
First received: January 25, 2007
Last updated: July 18, 2012
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Neoplastic Syndrome
Drug: motesanib diphosphate
Drug: octreotide acetate
Genetic: gene expression analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
Procedure: computed tomography
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Progression-free survival at 4 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response (complete or partial response, progressive disease, or stable disease) as measured by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity and tolerability [ Designated as safety issue: Yes ]
  • Effect of AMG 706 on markers in tumor cells [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: September 2008
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  • No small cell lung cancer, medullary thyroid cancer, paraganglioma, or pheochromocytoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to receive a contrast-enhanced CT scan
  • No known history of allergic reactions to AMG 706 or derivatives or to octreotide acetate injections
  • No 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)
  • No requirement for IV alimentation
  • 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)
  • AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • LVEF ≥ institutional lower limit of normal as evaluated by echocardiography or 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
  • No 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
  • No history of arterial or venous thrombosis within the past 12 months

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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
  • No prior procedures that would adversely affect intestinal absorption
  • No prior anti-vascular endothelial growth factors
  • No concurrent chemotherapy or radiation therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427349

  Hide Study Locations
Locations
United States, Illinois
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, United States, 60402
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
La Grange Oncology Associates - Geneva
Naperville, Illinois, United States, 60563
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States, 60714
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Bettendorf, Iowa, United States, 52722
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
St. Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Dakota
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wisconsin
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Kyle D. Holen, MD University of Wisconsin, Madison
Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center
Investigator: Peter J. O'Dwyer, MD, BCh Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT00427349     History of Changes
Other Study ID Numbers: CDR0000526256, ECOG-E4206
Study First Received: January 25, 2007
Last Updated: July 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Syndrome
Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Disease
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 20, 2014