Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
Gastrinoma, Glucagonoma, Insulinoma
About this trial
This is an interventional treatment trial for Gastrinoma focused on measuring temozolomide, capecitabine, pancreatic neuroendocrine tumor
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Small cell carcinoma
- Prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy
- Receiving any other investigational agents while on study treatment
- Receiving Coumadin while on treatment; other anticoagulants are allowed
- Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis are ineligible
- Active or uncontrolled infection or serious medical or psychiatric illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
- Absorption issues that would limit the ability to absorb study agents
Patients with a history of the following within 12 months of study entry:
- Arterial thromboembolic events
- Unstable angina
- Myocardial Infarction
- Symptomatic peripheral vascular disease
Patients with previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:
- Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ OR
- Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR
- Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 years
- Pregnant or breast-feeding
Sites / Locations
- Kaiser Anaheim Medical Center
- Kaiser Permanente-Deer Valley Medical Center
- Kaiser Permanente Medical Group - Baldwin Park
- Kaiser Foundation Hospital
- Alta Bates Summit Medical Center-Herrick Campus
- Mills - Peninsula Hospitals
- Kaiser Permanente Hospital
- Kaiser Permanente, Fremont
- Kaiser Permanente
- Kaiser Permanente - Harbor City
- Kaiser Permanente, Hayward
- Southern California Permanente Medical Group
- Kaiser Permanente Los Angeles Medical Center
- University of Southern California/Norris Cancer Center
- Kaiser Permanente-West Los Angeles
- Cedars-Sinai Medical Center
- Kaiser Permanente-Modesto
- Sutter Cancer Research Consortium
- Kaiser Permanente-Oakland
- University of California Medical Center At Irvine-Orange Campus
- Kaiser Permanente - Panorama City
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente Medical Center
- Kaiser Permanente-Roseville
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente at San Diego
- Kaiser Permanente
- Kaiser Permanente-San Francisco
- UCSF-Mount Zion
- California Pacific Medical Center
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente Health Care
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Stanford University Hospitals and Clinics
- Kaiser Permanente-Stockton
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center
- Kaiser Permanente-Walnut Creek
- Kaiser Permanente
- Saint Francis Hospital and Medical Center
- Middlesex Hospital
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- Edna Williams Cancer Center at the Baptist Cancer Institute
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Florida Hospital
- H. Lee Moffitt Cancer Center and Research Institute
- Oncare Hawaii Inc-Pali Momi
- Pali Momi Medical Center
- Oncare Hawaii Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii
- OnCare Hawaii-Liliha
- Oncare Hawaii Inc-Kuakini
- Kaiser Permanente Moanalua Medical Center
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Regional Medical Center
- Illinois CancerCare-Bloomington
- Saint Joseph Medical Center
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- University of Illinois
- Cancer Care Center of Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare Galesburg
- Illinois CancerCare-Galesburg Cottage Plaza Office
- Hematology Oncology Associates of Illinois-Highland Park
- Hinsdale Hematology Oncology Associates Incorporated
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- North Shore Hematology Oncology
- Illinois CancerCare-Macomb
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Illinois Cancer Specialists-Niles
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Pekin Cancer Treatment Center
- Illinois CancerCare-Pekin
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- SwedishAmerican Regional Cancer Center/ACT
- Hematology Oncology Associates of Illinois - Skokie
- Memorial Medical Center
- Franciscan Saint Francis Health-Indianapolis
- Reid Hospital and Health Care Services
- Mary Greeley Medical Center
- McFarland Clinic PC-William R Bliss Cancer Center
- Constantinou, Costas L MD (UIA Investigator)
- McFarland Clinic PC-Boone
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Oncology Hematology Care Incorporated
- Ochsner Health Center-Summa
- Ochsner Medical Center Jefferson
- Boston Medical Center
- Lahey Hospital and Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- University of Michigan University Hospital
- Oakwood Hospital
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Metro-Minnesota CCOP
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Central Care Cancer Center-Carrie J Babb Cancer Center
- CoxHealth Cancer Center
- Saint Francis Medical Center
- Southeast Cancer Center
- Capital Region Medical Center-Goldschmidt Cancer Center
- Phelps County Regional Medical Center
- Saint John's Clinic-Rolla-Cancer and Hematology
- Saint Louis Cancer and Breast Institute-South City
- Missouri Baptist Medical Center
- Saint John's Mercy Medical Center
- Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Nebraska Methodist Hospital
- Nevada Cancer Research Foundation CCOP
- Cooper Hospital University Medical Center
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Virtua West Jersey Hospital Voorhees
- New York Oncology Hematology PC - Albany
- New York Oncology Hematology PC -Albany Medical Center
- New York Oncology Hematology PC - Amsterdam
- Montefiore Medical Center-Weiler Division
- Montefiore Medical Center
- New York Oncology Hematology PC-Hudson
- New York Oncology Hematology PC - Latham
- New York Oncology Hematology PC - Rexford
- University of Rochester
- New York Oncology Hematology PC - Troy
- Kinston Medical Specialists PA
- Iredell Memorial Hospital
- Akron General Medical Center
- Cleveland Clinic Cancer Center Beachwood
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Adena Regional Medical Center
- Oncology and Hematology Care Incorporated
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc - Kenwood
- Oncology and Hematology Care Inc - Blue Ash
- Oncology Hematology Care Inc - Western Hills
- University of Cincinnati
- Case Western Reserve University
- Cleveland Clinic Foundation
- Ohio State University Medical Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus CCOP
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Dayton CCOP
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Saint Rita's Medical Center
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center-Strongsville
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Greene Memorial Hospital
- Genesis HealthCare System
- University of Oklahoma Health Sciences Center
- Tulsa Cancer Institute
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology at Evangelical Community Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Geisinger Medical Oncology-Pottsville
- Geisinger Medical Group
- Reading Hospital
- Geisinger Wyoming Valley
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute/Greenville CCOP
- Greenville Health System Cancer Institute-Greer
- Vanderbilt Cancer Center
- Fredericksburg Oncology Inc
- Gundersen Lutheran
- University of Wisconsin Hospital and Clinics
- Froedtert and the Medical College of Wisconsin
- Cancer Center of Western Wisconsin
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A (temozolomide)
Arm B (temozolomide and capecitabine)
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.
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.