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This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05247905 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Alliance for Clinical Trials in Oncology |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Timothy J. b, MD |
| Principal Investigator Affiliation | Mayo Clinic |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Active, not recruiting |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Metastatic Pancreatic Neuroendocrine Tumor, Unresectable Pancreatic Neuroendocrine Carcinoma |
This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors. The primary and secondary objectives of the study: PRIMARY OBJECTIVE:
Experimental: Arm I (lutetium Lu 177 dotatate)
Patients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (capecitabin, temozolomide)
Patients receive capecitabine PO BID days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Drug: - Lutetium Lu 177 Dotatate
Given IV
Drug: - Capecitabine
Given PO
Drug: - Temozolomide
Given PO
Other: - Quality-of-Life Assessment
Ancillary studies
Other: - Questionnaire Administration
Ancillary studies
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Status
Address
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Status
Address
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Status
Address
Epic Care-Dublin
Dublin, California, 94568
Status
Address
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Status
Address
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Status
Address
Cedars Sinai Medical Center
Los Angeles, California, 90048
Status
Address
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Status
Address
Bay Area Tumor Institute
Oakland, California, 94609
Status
Address
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
Status
Address
Epic Care Cyberknife Center
Walnut Creek, California, 94597
Status
Address
BASS Medical Group - Lennon
Walnut Creek, California, 94598
Status
Address
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Status
Address
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Status
Address
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Status
Address
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Status
Address
The Women's Imaging Center
Denver, Colorado, 80209
Status
Address
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Status
Address
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Status
Address
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Status
Address
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Status
Address
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Status
Address
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
Status
Address
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
Status
Address
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
Status
Address
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
Status
Address
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
Status
Address
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501
Status
Address
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
Status
Address
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Status
Address
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Status
Address
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Status
Address
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Status
Address
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Status
Address
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Status
Address
Yale University
New Haven, Connecticut, 06520
Status
Address
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Status
Address
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, 06477
Status
Address
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
Status
Address
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790
Status
Address
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Status
Address
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
Status
Address
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Status
Address
Sibley Memorial Hospital
Washington, District of Columbia, 20016
Status
Address
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Status
Address
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Status
Address
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Status
Address
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Status
Address
Illinois CancerCare-Canton
Canton, Illinois, 61520
Status
Address
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Status
Address
SIH Cancer Institute
Carterville, Illinois, 62918
Status
Address
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Status
Address
Centralia Oncology Clinic
Centralia, Illinois, 62801
Status
Address
Northwestern University
Chicago, Illinois, 60611
Status
Address
University of Illinois
Chicago, Illinois, 60612
Status
Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Status
Address
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Status
Address
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Status
Address
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Status
Address
Decatur Memorial Hospital
Decatur, Illinois, 62526
Status
Address
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Status
Address
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Status
Address
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Status
Address
Crossroads Cancer Center
Effingham, Illinois, 62401
Status
Address
Advocate Sherman Hospital
Elgin, Illinois, 60123
Status
Address
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Status
Address
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Status
Address
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Status
Address
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Status
Address
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Status
Address
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Status
Address
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Status
Address
Condell Memorial Hospital
Libertyville, Illinois, 60048
Status
Address
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Status
Address
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Status
Address
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Status
Address
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Status
Address
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Status
Address
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Status
Address
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Status
Address
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Status
Address
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Status
Address
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Status
Address
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Status
Address
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Status
Address
Illinois CancerCare-Peru
Peru, Illinois, 61354
Status
Address
Valley Radiation Oncology
Peru, Illinois, 61354
Status
Address
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Status
Address
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Status
Address
Springfield Clinic
Springfield, Illinois, 62702
Status
Address
Springfield Memorial Hospital
Springfield, Illinois, 62781
Status
Address
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Status
Address
Illinois CancerCare - Washington
Washington, Illinois, 61571
Status
Address
Mercy Health - Paducah Cancer Center
Paducah, Kentucky, 42003
Status
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Status
Address
Boston Medical Center
Boston, Massachusetts, 02118
Status
Address
Hickman Cancer Center
Adrian, Michigan, 49221
Status
Address
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162
Status
Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Status
Address
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187
Status
Address
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Status
Address
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Status
Address
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Status
Address
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Status
Address
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
Status
Address
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
Status
Address
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Status
Address
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Status
Address
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Status
Address
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Status
Address
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
Status
Address
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Status
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Status
Address
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
Status
Address
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
Status
Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
Status
Address
Mount Sinai Hospital
New York, New York, 10029
Status
Address
State University of New York Upstate Medical University
Syracuse, New York, 13210
Status
Address
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537
Status
Address
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623
Status
Address
Saint Vincent Hospital
Erie, Pennsylvania, 16544
Status
Address
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
Status
Address
Forbes Hospital
Monroeville, Pennsylvania, 15146
Status
Address
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Status
Address
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Status
Address
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090
Status
Address
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
Status
Address
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Status
Address
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Status
Address
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Status
Address
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Status
Address
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Status
Address
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Status
Address
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Status
Address
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Status
Address
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Status
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Status
Address
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Status
Address
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Status
Address
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Status
Address
Jefferson Healthcare
Port Townsend, Washington, 98368
Status
Address
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Status
Address
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Status
Address
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Status
Address
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Status
Address
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Status
Address
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Status
Address
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Status
Address
Aurora Health Center - Greenfield
Greenfield, Wisconsin, 53228
Status
Address
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Status
Address
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848
Status
Address
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Status
Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Status
Address
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Status
Address
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Status
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Status
Address
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Status
Address
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Status
Address
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Status
Address
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Status
Address
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Status
Address
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Status
Address
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Status
Address
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Status
Address
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
Status
Address
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
Status
Address
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Status
Address
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Status
Address
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Status
Address
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494
