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

Trial Status: Active

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 to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, 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.

Inclusion Criteria

  • Documentation of disease * Histologic documentation: Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma * Stage: Advanced (metastatic or unresectable primary) disease * Tumor site: Histologically-proven pheochromocytoma or paraganglioma * Radiographic evaluation: Radiographic evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in the 12 months prior to registration
  • Measurable disease * Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as >= 1 cm with computed tomography (CT) or magnetic resonance imaging (MRI) (or >= 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung
  • Prior treatment with other chemotherapy, radiotherapy (including peptide radionuclide receptor therapy [PRRT]), or surgery must be completed >= 28 days prior to registration. Patients must have recovered from any effects of any major surgery prior to registration
  • Prior treatment with radiolabeled metaiodobenzylguanidine (MIBG) must be completed >= 12 weeks prior to registration and lifetime cumulative 131I-MIBG dose must be < 1000 MBq kg-1 (36 mCi kg-1)
  • Prior treatment with antibiotics must be completed >= 7 days prior to registration
  • Contraception * Therapy utilized in this trial is associated with medium/high fetal risk * Women of childbearing potential and their partners, who are sexually active, must agree to use two highly effective forms of contraception in combination. This should be started from the time of registration and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug(s), or they must totally/truly abstain from any form of sexual intercourse * Male patients must use a condom during treatment and for 3 months after the last dose of study drug(s) when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Male patients should not donate sperm throughout the period of taking study drug(s) and for 3 months following the last dose of study drug(s)
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 10 mg/dL * In the absence of transfusion within the previous 24 hours
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) * Except in the case of Gilbert’s syndrome, then total bilirubin must be =< 3.0 x ULN
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x ULN
  • Creatinine < 1.5 x ULN OR calculated (calc.) creatinine clearance > 50 mL/min * Calculated by Cockcroft-Gault equation
  • Patients with human immunodeficiency virus (HIV) positivity are allowed if CD4 count > 250 cells/uL and they have an undetectable HIV viral load within 6 months of registration

Exclusion Criteria

  • No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor
  • No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • No indication of uncontrolled, potentially reversible cardiac condition(s) as determined by investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 msec, electrolyte disturbances, etc.) and no known congenital long QT syndrome
  • No extensive bilateral lung disease or pneumonitis
  • No abnormal organ or bone marrow function =< 28 days prior to registration
  • No active infection
  • No history of myelodysplastic syndrome (MDS) (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia
  • No known gastrointestinal condition(s) that might predispose for drug intolerability or poor drug absorption
  • No known medical condition causing an inability to swallow oral formulations of agents
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PARP inhibitors
  • Concurrent use of combination antiretroviral therapy (ART) is not permitted
  • Chronic concomitant treatment with strong or moderate CYP3A4 inducers or inhibitors is not allowed. Patients must discontinue the agent(s) >= 21 days prior to registration; enzalutamide and/or phenobarbital must be discontinued >= 5 weeks prior to registration

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
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Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Radiation Therapy Center
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Katmai Oncology Group
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California

Burbank
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Florida

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Holy Cross Hospital
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Jacksonville
Mayo Clinic in Florida
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Idaho

Boise
Saint Luke's Cancer Institute - Boise
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Phone: 208-381-2774
Fruitland
Saint Luke's Cancer Institute - Fruitland
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Meridian
Saint Luke's Cancer Institute - Meridian
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Phone: 208-381-2774
Nampa
Saint Luke's Cancer Institute - Nampa
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Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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Illinois

Chicago
University of Chicago Comprehensive Cancer Center
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Phone: 773-702-8222
New Lenox
UC Comprehensive Cancer Center at Silver Cross
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Orland Park
University of Chicago Medicine-Orland Park
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Massachusetts

Boston
Dana-Farber Cancer Institute
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Phone: 877-442-3324

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
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IHA Hematology Oncology Consultants-Brighton
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Saint Joseph Mercy Brighton
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Canton
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Saint Joseph Mercy Canton
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Caro
Caro Cancer Center
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Chelsea
IHA Hematology Oncology Consultants-Chelsea
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Saint Joseph Mercy Chelsea
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Clarkston
Hematology Oncology Consultants-Clarkston
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Newland Medical Associates-Clarkston
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Detroit
Ascension Saint John Hospital
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East China
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Flint
Genesee Cancer and Blood Disease Treatment Center
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Genesee Hematology Oncology PC
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Genesys Hurley Cancer Institute
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Hurley Medical Center
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Grosse Pointe Woods
Academic Hematology Oncology Specialists
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Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
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Michigan Breast Specialists-Grosse Pointe Woods
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Lansing
Sparrow Hospital
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Livonia
Hope Cancer Clinic
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Saint Mary Mercy Hospital
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Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
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Michigan Breast Specialists-Macomb Township
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Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
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Pontiac
21st Century Oncology-Pontiac
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Hope Cancer Center
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Newland Medical Associates-Pontiac
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Saint Joseph Mercy Oakland
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Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
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Saginaw
Ascension Saint Mary's Hospital
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Oncology Hematology Associates of Saginaw Valley PC
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Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
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Tawas City
Ascension Saint Joseph Hospital
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Warren
Advanced Breast Care Center PLLC
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Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Macomb Professional Building
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Macomb Hematology Oncology PC
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Michigan Breast Specialists-Warren
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Phone: 734-712-3671
Saint John Macomb-Oakland Hospital
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West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
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Ypsilanti
Huron Gastroenterology PC
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IHA Hematology Oncology Consultants-Ann Arbor
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Phone: 734-712-3671

Minnesota

Burnsville
Fairview Ridges Hospital
Status: ACTIVE
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Phone: 952-993-1517
Minnesota Oncology - Burnsville
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Phone: 952-993-1517
Cambridge
Cambridge Medical Center
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Coon Rapids
Mercy Hospital
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Edina
Fairview Southdale Hospital
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Fridley
Unity Hospital
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Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
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Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
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Phone: 952-993-1517
Saint John's Hospital - Healtheast
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Minneapolis
Abbott-Northwestern Hospital
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Phone: 952-993-1517
Health Partners Inc
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Hennepin County Medical Center
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Monticello
Monticello Cancer Center
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New Ulm
New Ulm Medical Center
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Princeton
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Robbinsdale
North Memorial Medical Health Center
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Rochester
Mayo Clinic in Rochester
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Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Saint Paul
Regions Hospital
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United Hospital
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Shakopee
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Stillwater
Lakeview Hospital
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Waconia
Ridgeview Medical Center
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Willmar
Rice Memorial Hospital
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Woodbury
Minnesota Oncology Hematology PA-Woodbury
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Wyoming
Fairview Lakes Medical Center
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Montana

Missoula
Saint Patrick Hospital - Community Hospital
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Phone: 406-327-3118

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
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Memorial Sloan Kettering Monmouth
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Montvale
Memorial Sloan Kettering Bergen
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New York

Commack
Memorial Sloan Kettering Commack
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Phone: 212-639-7592
New York
Memorial Sloan Kettering Cancer Center
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Phone: 212-639-7592
Uniondale
Memorial Sloan Kettering Nassau
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West Harrison
Memorial Sloan Kettering Westchester
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Oregon

Bend
Saint Charles Health System
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Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
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Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
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Phone: 503-215-2614
Coos Bay
Bay Area Hospital
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Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
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Phone: 503-215-2614
Portland
Oregon Health and Science University
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Phone: 503-494-1080
Providence Portland Medical Center
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Phone: 503-215-2614
Providence Saint Vincent Medical Center
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Redmond
Saint Charles Health System-Redmond
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Phone: 541-706-2909

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
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Phone: 734-712-3671
Bethlehem
Lehigh Valley Hospital - Muhlenberg
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Phone: 734-712-3671
East Stroudsburg
Pocono Medical Center
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Hazleton
Lehigh Valley Hospital-Hazleton
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Phone: 734-712-3671

Utah

Farmington
Farmington Health Center
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Phone: 888-424-2100
Salt Lake City
Huntsman Cancer Institute / University of Utah
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Phone: 888-424-2100
University of Utah Sugarhouse Health Center
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Phone: 888-424-2100

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
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Phone: 360-412-8958
Bellingham
PeaceHealth Saint Joseph Medical Center
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Phone: 360-788-8238
Centralia
Providence Regional Cancer System-Centralia
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Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
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Phone: 206-215-3086
Everett
Providence Regional Cancer Partnership
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Phone: 425-261-3529
Issaquah
Swedish Cancer Institute-Issaquah
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Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
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Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
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Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
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Phone: 360-514-2016
Seattle
Pacific Gynecology Specialists
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Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
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Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
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Phone: 206-215-3086
Swedish Medical Center-First Hill
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Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
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Shelton
Providence Regional Cancer System-Shelton
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Phone: 360-412-8958
Vancouver
PeaceHealth Southwest Medical Center
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Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
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Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958

Wisconsin

New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

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.

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 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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Jaydira Del Rivero

  • Primary ID A021804
  • Secondary IDs NCI-2020-03379
  • Clinicaltrials.gov ID NCT04394858