AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors
3 other identifiers
interventional
46
1 country
112
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2008
Longer than P75 for phase_2
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2007
CompletedStudy Start
First participant enrolled
November 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 4, 2015
CompletedJuly 5, 2023
June 1, 2023
5.9 years
January 25, 2007
May 19, 2015
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Four-month Progression-free Survival Rate
Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.
assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four
Secondary Outcomes (2)
Overall Survival
assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years
Objective Response Rate
assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years
Study Arms (1)
AMG 706+Octreotide
EXPERIMENTALPatients 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.
Interventions
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 AM. 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.
Eligibility Criteria
You may qualify if:
- 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)
- +7 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, 60402, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, 61265, United States
La Grange Oncology Associates - Geneva
Naperville, Illinois, 60563, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, 60714, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Hematology & Oncology Care
Bettendorf, Iowa, 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Creighton University Medical Center
Omaha, Nebraska, 68131-2197, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, 18201, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Related Publications (1)
Lubner S, Feng Y, Mulcahy M, O'Dwyer P, Giang GY, Hinshaw JL, Deming D, Klein L, Teitelbaum U, Payne J, Engstrom P, Stella P, Meropol N, Benson A. E4206: AMG 706 and Octreotide in Patients with Low-Grade Neuroendocrine Tumors. Oncologist. 2018 Sep;23(9):1006-e104. doi: 10.1634/theoncologist.2018-0294. Epub 2018 May 31.
PMID: 29853660DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- STUDY CHAIR
Mary Mulcahy, MD
Robert H. Lurie Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2007
First Posted
January 29, 2007
Study Start
November 7, 2008
Primary Completion
October 1, 2014
Study Completion
April 1, 2015
Last Updated
July 5, 2023
Results First Posted
June 4, 2015
Record last verified: 2023-06