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Brief Title: Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
Official Title: A Prospective, Multi-Institutional Phase II Trial Evaluating Temozolomide vs. Temozolomide and Olaparib for Advanced Pheochromocytoma and Paraganglioma
Study ID: NCT04394858
Brief Summary: This phase II trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Poly (adenosine diphosphate \[ADP\]-ribose) polymerases (PARPs) are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as 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. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.
Detailed Description: PRIMARY OBJECTIVE: I. To compare the progression-free survival (PFS) of patients with advanced pheochromocytoma and paraganglioma (APP) receiving temozolomide (dose dense) and olaparib to that of patients receiving temozolomide (pulse dose) alone. SECONDARY OBJECTIVES: I. To compare the overall survival (OS) of patients with APP receiving temozolomide (dose dense) and olaparib versus (vs.) temozolomide (pulse dose) alone. II. To compare the objective response rate (ORR) associated with temozolomide (dose dense) and olaparib vs. temozolomide (pulse dose) alone in patients with APP. III. To evaluate and compare the toxicity profile of temozolomide-based combinations (temozolomide \[dose dense\] and olaparib vs. temozolomide \[pulse dose\]) in patients with APP using Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes (PRO)-CTCAE. OTHER OBJECTIVE: I. Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue. EXPLORATORY OBJECTIVES: I. To assess biochemical response: serum catecholamines and metanephrines; urine catecholamines and metanephrines. II. To assess biomolecular markers associated with clinical outcome: germline succinyl dehydrogenase (SDH) mutations and tumor status of the repair enzyme methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive temozolomide orally (PO) once daily (QD) and olaparib PO twice daily (BID) on days 1-7. Treatment with temozolomide repeats every 21 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Cycles of olaparib repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) with contrast or magnetic resonance imaging (MRI) throughout the study and undergo mandatory collection of blood samples prior to treatment. Patients may optionally undergo collection of blood samples at the time of progression. ARM II: Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with contrast or MRI throughout the study and undergo mandatory collection of blood samples prior to treatment. Patients may optionally undergo collection of blood samples at the time of progression. Patients discontinuing treatment due to reasons other than disease progression are followed every 8 weeks until disease progression, then every 6 months until 5 years after start of treatment. Patients discontinuing treatment due to disease progression are followed every 6 months for 5 years after start of treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alaska Women's Cancer Care, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Carle at The Riverfront, Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Illinois CancerCare-Dixon, Dixon, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, 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
University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Illinois CancerCare - Washington, Washington, Illinois, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill, Newton, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States
Trinity Health Medical Center - Brighton, Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, United States
Trinity Health Medical Center - Canton, Canton, Michigan, United States
Caro Cancer Center, Caro, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston, Clarkston, Michigan, United States
Newland Medical Associates-Clarkston, Clarkston, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States
Genesee Hematology Oncology PC, Flint, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Academic Hematology Oncology Specialists, Grosse Pointe Woods, Michigan, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States
Michigan Breast Specialists-Grosse Pointe Woods, Grosse Pointe Woods, Michigan, United States
University of Michigan Health - Sparrow Lansing, Lansing, Michigan, United States
Hope Cancer Clinic, Livonia, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States
Michigan Breast Specialists-Macomb Township, Macomb, Michigan, United States
Saint Mary's Oncology/Hematology Associates of Marlette, Marlette, Michigan, United States
Hope Cancer Center, Pontiac, Michigan, United States
Michigan Healthcare Professionals Pontiac, Pontiac, Michigan, United States
Newland Medical Associates-Pontiac, Pontiac, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac, Michigan, United States
Great Lakes Cancer Management Specialists-Rochester Hills, Rochester Hills, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, United States
Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, United States
Ascension Saint Joseph Hospital, Tawas City, Michigan, United States
Advanced Breast Care Center PLLC, Warren, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, United States
Macomb Hematology Oncology PC, Warren, Michigan, United States
Michigan Breast Specialists-Warren, Warren, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch, West Branch, Michigan, United States
Huron Gastroenterology PC, Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Minnesota Oncology - Burnsville, Burnsville, Minnesota, United States
Cambridge Medical Center, Cambridge, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Health Partners Inc, Minneapolis, Minnesota, United States
Monticello Cancer Center, Monticello, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
Fairview Northland Medical Center, Princeton, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Fairview Lakes Medical Center, Wyoming, Minnesota, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Cancer Centers of Southwest Oklahoma Research, Lawton, Oklahoma, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Saint Charles Health System, Bend, Oregon, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Providence Willamette Falls Medical Center, Oregon City, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Saint Charles Health System-Redmond, Redmond, Oregon, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Pocono Medical Center, East Stroudsburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton, Hazleton, Pennsylvania, United States
Farmington Health Center, Farmington, Utah, United States
University of Utah Sugarhouse Health Center, Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Providence Regional Cancer System-Centralia, Centralia, Washington, United States
Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Providence Regional Cancer System-Lacey, Lacey, Washington, United States
PeaceHealth Saint John Medical Center, Longview, Washington, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Swedish Medical Center-Ballard Campus, Seattle, Washington, United States
Swedish Medical Center-Cherry Hill, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton, Shelton, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
Providence Regional Cancer System-Yelm, Yelm, Washington, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Name: Jaydira Del Rivero
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR