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Spots Global Cancer Trial Database for Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jaydira Del Rivero

Affiliation: Alliance for Clinical Trials in Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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