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Brief Title: Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors
Official Title: Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors
Study ID: NCT05247905
Brief Summary: 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.
Detailed Description: 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: I. To determine the differences in median progression-free survival (PFS) for lutetium Lu 177 dotatate peptide receptor radionuclide therapy (PRRT) when compared to capecitabine and temozolomide (CAPTEM) in patients with locally advanced or metastatic progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs). SECONDARY OBJECTIVES: I. To evaluate and compare the overall survival (OS) of patients receiving lutetium Lu 177 dotatate versus (vs.) CAPTEM. II. To evaluate and compare time to response, time to maximum response, and overall response rates (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 between both arms. III. To evaluate and compare duration of response and time to progression among both arms. IV. To evaluate and compare treatment related toxicities between the arms. V. To compare global health status/quality of life as measured with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 from baseline through 18 months between patients with pNET treated with lutetium Lu 177 dotatate PRRT versus capecitabine and temozolomide. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive lutetium Lu 177 dotatate intravenously (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. ARM II: Patients receive capecitabine orally (PO) twice daily (BID) days 1-14 and temozolomide PO once daily (QD) on days 10-14. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
Tower Cancer Research Foundation, Beverly Hills, California, United States
Epic Care-Dublin, Dublin, California, United States
Bay Area Breast Surgeons Inc, Emeryville, California, United States
Epic Care Partners in Cancer Care, Emeryville, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
Bay Area Tumor Institute, Oakland, California, United States
Torrance Memorial Physician Network - Cancer Care, Torrance, California, United States
Epic Care Cyberknife Center, Walnut Creek, California, United States
Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, United States
Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Advocate Good Shepherd Hospital, Barrington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Memorial Hospital of Carbondale, Carbondale, Illinois, United States
SIH Cancer Institute, Carterville, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Northwestern University, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center, Chicago, Illinois, United States
AMG Crystal Lake - Oncology, Crystal Lake, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States
Illinois CancerCare-Dixon, Dixon, Illinois, United States
Advocate Good Samaritan Hospital, Downers Grove, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Advocate Sherman Hospital, Elgin, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Advocate South Suburban Hospital, Hazel Crest, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
AMG Libertyville - Oncology, Libertyville, Illinois, United States
Condell Memorial Hospital, Libertyville, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Advocate Outpatient Center - Oak Lawn, Oak Lawn, Illinois, United States
Northwestern Medicine Orland Park, Orland Park, Illinois, United States
University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Advocate Lutheran General Hospital, Park Ridge, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Illinois CancerCare - Washington, Washington, Illinois, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Hickman Cancer Center, Adrian, Michigan, United States
Toledo Clinic Cancer Centers-Monroe, Monroe, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Sanford Cancer Center Worthington, Worthington, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington, Farmington, Missouri, United States
MU Health Care Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, United States
Nebraska Medicine-Bellevue, Bellevue, Nebraska, United States
Cancer Partners of Nebraska - Pine Lake, Lincoln, Nebraska, United States
Cancer Partners of Nebraska, Lincoln, Nebraska, United States
Nebraska Medicine-Village Pointe, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Mount Sinai Hospital, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Saint Vincent Hospital, Erie, Pennsylvania, United States
Jefferson Hospital, Jefferson Hills, Pennsylvania, United States
Forbes Hospital, Monroeville, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
West Penn Hospital, Pittsburgh, Pennsylvania, United States
Wexford Health and Wellness Pavilion, Wexford, Pennsylvania, United States
Smilow Cancer Hospital Care Center - Westerly, Westerly, Rhode Island, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Collierville, Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, United States
Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, United States
Aurora Saint Luke's South Shore, Cudahy, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Aurora Health Care Germantown Health Center, Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
Aurora Health Center - Greenfield, Greenfield, Wisconsin, United States
Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, United States
Marshfield Medical Center - Ladysmith, Ladysmith, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette, Marinette, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine, Racine, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States
Aurora Medical Center in Summit, Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, United States
Marshfield Clinic-Wausau Center, Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Marshfield Medical Center - Weston, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Name: Timothy J. b, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR