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A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Neoplastic Syndrome

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Safety Issue:

No

Principal Investigator

Kyle D. Holen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000526256

NCT ID:

NCT00427349

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Neoplastic Syndrome
  • 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
  • Neoplasms
  • Carcinoid Tumor
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Adenoma, Islet Cell

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
St. Rita's Medical CenterLima, Ohio  45801
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Hinsdale, Illinois  60521
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Southwest Medical CenterLiberal, Kansas  67901
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Bettendorf, Iowa  52722
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Hematology Oncology Associates of Illinois - BerwynBerwyn, Illinois  60402
La Grange Oncology Associates - GenevaNaperville, Illinois  60563
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265