Testing the Addition of Olaparib to Usual Chemotherapy for Advanced Neuroendocrine Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04394858
This study is exploring whether adding the drug olaparib to the standard chemotherapy treatment, temozolomide, can better treat advanced neuroendocrine cancers like pheochromocytoma or paraganglioma that have spread or cannot be surgically removed.
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Program Overview
This phase II clinical trial is investigating if combining olaparib with the usual chemotherapy drug, temozolomide, is more effective in treating patients with advanced neuroendocrine cancer, specifically pheochromocytoma or paraganglioma. These cancers have either spread to other parts of the body or cannot be removed by surgery. Olaparib is a type of drug that stops cancer cells from repairing themselves, potentially stopping their growth. Temozolomide works by killing cancer cells or stopping them from dividing. The study aims to see if this combination can shrink or stabilize the cancer better than using temozolomide alone.
Description
The main goal of this study is to compare how long patients with advanced pheochromocytoma and paraganglioma live without their cancer getting worse when treated with both temozolomide and olaparib versus temozolomide alone. Researchers will also look at overall survival rates, how well the cancer responds to treatment, and any side effects experienced by patients.
Patients will be randomly assigned to one of two groups. In the first group, patients will take temozolomide daily and olaparib twice daily for one week, repeating this cycle every 21 days for up to 13 cycles, as long as the cancer does not progress and side effects are manageable. In the second group, patients will take temozolomide daily for five days, repeating this cycle every 28 days for up to 13 cycles, under the same conditions.
Throughout the study, patients will undergo regular scans and blood tests to monitor their cancer and overall health. If treatment is stopped for reasons other than cancer progression, patients will be followed up every 8 weeks until the cancer progresses, and then every 6 months for up to 5 years. If treatment is stopped due to cancer progression, follow-ups will occur every 6 months for 5 years.
Eligibility Criteria
Inclusion Criteria
- Must have advanced pheochromocytoma or paraganglioma that has spread or cannot be surgically removed.
- Must have measurable disease that can be tracked by scans.
- Must have completed any previous treatments like chemotherapy or surgery at least 28 days before joining the study.
- Must not have had previous treatment with temozolomide, dacarbazine, or PARP inhibitors.
- Must not have had a bone marrow transplant.
- Must not be pregnant or nursing, and women of childbearing potential must have a negative pregnancy test before joining.
- Must agree to use effective contraception during the study and for a period after the last dose.
- Must be 18 years or older.
- Must have a good performance status, meaning they can carry out daily activities with minimal assistance.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must not have any uncontrolled heart conditions or extensive lung disease.
- Must not have any active infections or history of certain blood disorders.
- Must not have any conditions that affect drug absorption or cause difficulty swallowing pills.
- Must not be taking certain medications that interact with the study drugs.
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