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

Conditions

• Advanced Adrenal Gland Pheochromocytoma
• Advanced Paraganglioma
• Metastatic Adrenal Gland Pheochromocytoma
• Metastatic Paraganglioma
• Stage III Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8
• Stage IV Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8
• Unresectable Adrenal Gland Pheochromocytoma
• Unresectable Paraganglioma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography with Contrast — PROCEDURE
  Undergo CT with contrast
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Olaparib — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Temozolomide — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Mar 17, 2021

Status verified

Mar 2026

Primary completion

Mar 1, 2028

Completion

Mar 1, 2028

Study Design

Enrollment

46 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (temozolomide, olaparib)
  Patients receive temozolomide PO QD and olaparib PO 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 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.
• Active Comparator: Arm II (temozolomide)
  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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From randomization to the first documentation of disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) or death, assessed up to 5 years ]

Locations (163)

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