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Spots Global Cancer Trial Database for Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Timothy J. b, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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