A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors

Who is this study for? Patients with Recurrent Islet Cell Carcinoma, Somatostatinoma
What treatments are being studied? Capecitabine
Status: Active_not_recruiting
Location: See all (323) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient must have histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendocrine tumor

• Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained \<= 4 weeks prior to randomization and must be acquired by multiphasic CT or contrast magnetic resonance imaging (MRI)

• Date of last documented disease progression must be within 12 months from date of randomization

• Prior everolimus and/or sunitinib therapy is allowed, so long as it was discontinued \>= 4 weeks prior to randomization

• Concurrent somatostatin analogues are allowed provided that patients

‣ Have been on a stable dose for 8 weeks and

⁃ Have documented disease progression on that dose

• Chemoembolization is allowed if ≥ 4 weeks from study entry. There are 2 possible scenarios:

‣ If patient has hepatic disease only: they need to have progressed in the liver since chemoembolization and have measurable disease by RECIST 1.1 in order to be eligible.

⁃ If patient has hepatic and extrahepatic disease: they will need to have progressed inside OR outside the liver and have measureable disease by RECIST 1.1 in order to be eligible.

• Leukocytes \>= 3,000/mm\^3

• Absolute neutrophil count \>= 1,500/mm\^3

• Hemoglobin \>= 9 g/dL

• Platelets \>= 100,000/mm\^3

• Total bilirubin \<= institutional upper limit of normal (ULN) or \<= 1.5 X institutional ULN (if the patient has liver metastases)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \<= 3 X institutional ULN or (\<= 5 X institutional ULN if the patient has liver metastases)

• Serum creatinine \<= 1.5 X institutional ULN

• Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Patient must have life expectancy \>= 12 weeks all females of childbearing potential must have a blood test or urine study within =\< 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:

‣ Has not undergone a hysterectomy or bilateral oophorectomy; or

⁃ Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately

• Patient must be able to swallow pills

• Patient must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol

Locations
United States
California
Kaiser Anaheim Medical Center
Anaheim
Kaiser Permanente-Deer Valley Medical Center
Antioch
Kaiser Permanente Medical Group - Baldwin Park
Baldwin Park
Kaiser Foundation Hospital
Bellflower
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Mills - Peninsula Hospitals
Burlingame
Kaiser Permanente Hospital
Fontana
Kaiser Permanente, Fremont
Fremont
Kaiser Permanente
Fresno
Kaiser Permanente - Harbor City
Harbor City
Kaiser Permanente, Hayward
Hayward
Southern California Permanente Medical Group
Irvine
Cedars-Sinai Medical Center
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Kaiser Permanente-West Los Angeles
Los Angeles
University of Southern California/Norris Cancer Center
Los Angeles
Kaiser Permanente-Modesto
Modesto
Sutter Cancer Research Consortium
Novato
Kaiser Permanente-Oakland
Oakland
University of California Medical Center At Irvine-Orange Campus
Orange
Kaiser Permanente - Panorama City
Panorama City
Kaiser Permanente-Redwood City
Redwood City
Kaiser Permanente-Richmond
Richmond
Kaiser Permanente Medical Center
Riverside
Kaiser Permanente-Roseville
Roseville
Kaiser Permanente - Sacramento
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
Kaiser Permanente
San Diego
Kaiser Permanente at San Diego
San Diego
California Pacific Medical Center
San Francisco
Kaiser Permanente-San Francisco
San Francisco
UCSF-Mount Zion
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente Health Care
San Marcos
Kaiser Permanente-San Rafael
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Kaiser Permanente-Santa Rosa
Santa Rosa
Sutter Pacific Medical Foundation
Santa Rosa
Kaiser Permanente-South San Francisco
South San Francisco
Stanford University Hospitals and Clinics
Stanford
Kaiser Permanente-Stockton
Stockton
Kaiser Permanente Medical Center-Vacaville
Vacaville
Kaiser Permanente-Vallejo
Vallejo
Sutter Solano Medical Center
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Kaiser Permanente
Woodland Hills
Connecticut
Saint Francis Hospital and Medical Center
Hartford
Middlesex Hospital
Middletown
Delaware
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Christiana Gynecologic Oncology LLC
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Regional Hematology and Oncology PA
Newark
Beebe Health Campus
Rehoboth Beach
Nanticoke Memorial Hospital
Seaford
Christiana Care Health System-Wilmington Hospital
Wilmington
Florida
Edna Williams Cancer Center at the Baptist Cancer Institute
Jacksonville
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida Hospital
Orlando
H. Lee Moffitt Cancer Center and Research Institute
Tampa
Hawaii
Oncare Hawaii Inc-Pali Momi
‘aiea
Pali Momi Medical Center
‘aiea
Kaiser Permanente Moanalua Medical Center
Honolulu
Oncare Hawaii Inc-Kuakini
Honolulu
Oncare Hawaii Inc-POB II
Honolulu
OnCare Hawaii-Liliha
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
University of Hawaii
Honolulu
Castle Medical Center
Kailua
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic PC-William R Bliss Cancer Center
Ames
Constantinou, Costas L MD (UIA Investigator)
Bettendorf
McFarland Clinic PC-Boone
Boone
Medical Oncology and Hematology Associates-West Des Moines
Clive
Mercy Cancer Center-West Lakes
Clive
Iowa Lutheran Hospital
Des Moines
Iowa Methodist Medical Center
Des Moines
Iowa Oncology Research Association CCOP
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Des Moines
Medical Oncology and Hematology Associates-Laurel
Des Moines
Mercy Medical Center - Des Moines
Des Moines
McFarland Clinic PC-Jefferson
Jefferson
McFarland Clinic PC-Marshalltown
Marshalltown
Mercy Medical Center-Sioux City
Sioux City
Saint Luke's Regional Medical Center
Sioux City
Siouxland Hematology Oncology Associates
Sioux City
Mercy Medical Center-West Lakes
West Des Moines
Methodist West Hospital
West Des Moines
Idaho
Saint Alphonsus Regional Medical Center
Boise
Illinois
Illinois CancerCare-Bloomington
Bloomington
Saint Joseph Medical Center
Bloomington
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
Northwestern University
Chicago
University of Illinois
Chicago
Cancer Care Center of Decatur
Decatur
Decatur Memorial Hospital
Decatur
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare Galesburg
Galesburg
Illinois CancerCare-Galesburg Cottage Plaza Office
Galesburg
Hematology Oncology Associates of Illinois-Highland Park
Highland Park
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale
Presence Saint Mary's Hospital
Kankakee
Illinois CancerCare-Kewanee Clinic
Kewanee
North Shore Hematology Oncology
Libertyville
Illinois CancerCare-Macomb
Macomb
Loyola University Medical Center
Maywood
Garneau, Stewart C MD (UIA Investigator)
Moline
Porubcin, Michael MD (UIA Investigator)
Moline
Spector, David MD (UIA Investigator)
Moline
Trinity Medical Center
Moline
Illinois CancerCare-Monmouth
Monmouth
Good Samaritan Regional Health Center
Mount Vernon
Illinois Cancer Specialists-Niles
Niles
Community Cancer Center Foundation
Normal
Illinois CancerCare-Ottawa Clinic
Ottawa
Ottawa Regional Hospital and Healthcare Center
Ottawa
Illinois CancerCare-Pekin
Pekin
Pekin Cancer Treatment Center
Pekin
Illinois CancerCare-Peoria
Peoria
Illinois Oncology Research Association CCOP
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
Proctor Hospital
Peoria
Illinois CancerCare-Peru
Peru
Illinois CancerCare-Princeton
Princeton
SwedishAmerican Regional Cancer Center/ACT
Rockford
Hematology Oncology Associates of Illinois - Skokie
Skokie
Memorial Medical Center
Springfield
Indiana
Franciscan Saint Francis Health-Indianapolis
Indianapolis
Reid Hospital and Health Care Services
Richmond
Kansas
Cancer Center of Kansas - Chanute
Chanute
Cancer Center of Kansas - Dodge City
Dodge City
Cancer Center of Kansas - El Dorado
El Dorado
Cancer Center of Kansas - Fort Scott
Fort Scott
Cancer Center of Kansas-Independence
Independence
Cancer Center of Kansas-Kingman
Kingman
Lawrence Memorial Hospital
Lawrence
Cancer Center of Kansas-Liberal
Liberal
Cancer Center of Kansas-Manhattan
Manhattan
Cancer Center of Kansas - McPherson
Mcpherson
Cancer Center of Kansas - Newton
Newton
Cancer Center of Kansas - Parsons
Parsons
Cancer Center of Kansas - Pratt
Pratt
Cancer Center of Kansas - Salina
Salina
Cancer Center of Kansas - Wellington
Wellington
Associates In Womens Health
Wichita
Cancer Center of Kansas - Main Office
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Via Christi Regional Medical Center
Wichita
Wichita CCOP
Wichita
Cancer Center of Kansas - Winfield
Winfield
Kentucky
Oncology Hematology Care Incorporated
Crestview Hills
Louisiana
Ochsner Health Center-Summa
Baton Rouge
Ochsner Medical Center Jefferson
New Orleans
Massachusetts
Boston Medical Center
Boston
Lahey Hospital and Medical Center
Burlington
Michigan
Bixby Medical Center
Adrian
Hickman Cancer Center
Adrian
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan University Hospital
Ann Arbor
Oakwood Hospital
Dearborn
Saint John Hospital and Medical Center
Detroit
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Allegiance Health
Jackson
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Sparrow Hospital
Lansing
Saint Mary Mercy Hospital
Livonia
Community Cancer Center of Monroe
Monroe
Mercy Memorial Hospital
Monroe
Saint Joseph Mercy Oakland
Pontiac
Saint Joseph Mercy Port Huron
Port Huron
Saint Mary's of Michigan
Saginaw
Saint John Macomb-Oakland Hospital
Warren
Minnesota
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Fairview-Southdale Hospital
Edina
Unity Hospital
Fridley
Hutchinson Area Health Care
Hutchinson
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Hennepin County Medical Center
Minneapolis
New Ulm Medical Center
New Ulm
North Memorial Medical Health Center
Robbinsdale
Metro-Minnesota CCOP
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology and Hematology PA-Woodbury
Woodbury
Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar
CoxHealth Cancer Center
Branson
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City
Phelps County Regional Medical Center
Rolla
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield
Missouri Baptist Medical Center
St Louis
Saint John's Mercy Medical Center
St Louis
Saint Louis Cancer and Breast Institute-South City
St Louis
North Carolina
Kinston Medical Specialists PA
Kinston
Iredell Memorial Hospital
Statesville
Nebraska
Nebraska Methodist Hospital
Omaha
New Jersey
Cooper Hospital University Medical Center
Camden
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly
Virtua West Jersey Hospital Voorhees
Voorhees Township
Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas
New York
New York Oncology Hematology PC - Albany
Albany
New York Oncology Hematology PC -Albany Medical Center
Albany
New York Oncology Hematology PC - Amsterdam
Amsterdam
New York Oncology Hematology PC-Hudson
Hudson
New York Oncology Hematology PC - Latham
Latham
New York Oncology Hematology PC - Rexford
Rexford
University of Rochester
Rochester
Montefiore Medical Center
The Bronx
Montefiore Medical Center-Weiler Division
The Bronx
New York Oncology Hematology PC - Troy
Troy
Ohio
Akron General Medical Center
Akron
Cleveland Clinic Cancer Center Beachwood
Beachwood
Strecker Cancer Center-Belpre
Belpre
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green
Adena Regional Medical Center
Chillicothe
Oncology and Hematology Care Inc - Blue Ash
Cincinnati
Oncology and Hematology Care Incorporated
Cincinnati
Oncology Hematology Care Inc - Anderson
Cincinnati
Oncology Hematology Care Inc - Kenwood
Cincinnati
Oncology Hematology Care Inc - Western Hills
Cincinnati
University of Cincinnati
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Foundation
Cleveland
Columbus CCOP
Columbus
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel Health Center West
Columbus
Ohio State University Medical Center
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Dayton CCOP
Dayton
Good Samaritan Hospital - Dayton
Dayton
Grandview Hospital
Dayton
Miami Valley Hospital
Dayton
Samaritan North Health Center
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Delaware Radiation Oncology
Delaware
Grady Memorial Hospital
Delaware
Hematology Oncology Center Incorporated
Elyria
Mercy Cancer Center-Elyria
Elyria
Oncology Hematology Care Inc
Fairfield
Blanchard Valley Hospital
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Wayne Hospital
Greenville
Cleveland Clinic Cancer Center Independence
Independence
Kettering Medical Center
Kettering
Fairfield Medical Center
Lancaster
Lancaster Radiation Oncology
Lancaster
Lima Memorial Hospital
Lima
Saint Rita's Medical Center
Lima
Marietta Memorial Hospital
Marietta
Toledo Clinic Cancer Centers-Maumee
Maumee
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee
Hillcrest Hospital Cancer Center
Mayfield Heights
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Saint Charles Hospital
Oregon
Toledo Clinic Cancer Centers-Oregon
Oregon
Southern Ohio Medical Center
Portsmouth
North Coast Cancer Care
Sandusky
Springfield Regional Medical Center
Springfield
Cleveland Clinic Cancer Center-Strongsville
Strongsville
Flower Hospital
Sylvania
Mercy Hospital of Tiffin
Tiffin
Mercy Saint Anne Hospital
Toledo
Saint Vincent Mercy Medical Center
Toledo
The Toledo Hospital/Toledo Children's Hospital
Toledo
Toledo Clinic Cancer Centers-Toledo
Toledo
Toledo Community Hospital Oncology Program CCOP
Toledo
University of Toledo
Toledo
Upper Valley Medical Center
Troy
Fulton County Health Center
Wauseon
Saint Ann's Hospital
Westerville
Greene Memorial Hospital
Xenia
Genesis HealthCare System
Zanesville
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Tulsa Cancer Institute
Tulsa
Pennsylvania
Geisinger Medical Center
Danville
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Penn State Milton S Hershey Medical Center
Hershey
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg
Fox Chase Cancer Center
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Geisinger Medical Oncology-Pottsville
Pottsville
Geisinger Medical Group
State College
Reading Hospital
West Reading
Geisinger Wyoming Valley
Wilkes-barre
South Carolina
Greenville Health System Cancer Institute-Butternut
Greenville
Greenville Health System Cancer Institute/Greenville CCOP
Greenville
Greenville Health System Cancer Institute-Greer
Greer
Tennessee
Vanderbilt Cancer Center
Nashville
Virginia
Fredericksburg Oncology Inc
Fredericksburg
Wisconsin
Gundersen Lutheran
La Crosse
University of Wisconsin Hospital and Clinics
Madison
Froedtert and the Medical College of Wisconsin
Milwaukee
Cancer Center of Western Wisconsin
New Richmond
Time Frame
Start Date: 2013-08-08
Completion Date: 2025-12
Participants
Target number of participants: 144
Treatments
Experimental: Arm A (temozolomide)
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (temozolomide and capecitabine)
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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