Study on Lutathera and Olaparib for Inoperable Neuroendocrine Tumors in the Pancreas and Intestine

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04086485

Provider View

This clinical trial is exploring whether a combination of two drugs, Lutathera and Olaparib, can safely shrink neuroendocrine tumors in the pancreas and intestine that cannot be removed by surgery.

Patient Parameters

Program Overview

Neuroendocrine tumors are rare growths that can occur in the pancreas and intestines. This study aims to find out if a combination of two drugs, Lutathera and Olaparib, can help shrink these tumors without causing severe side effects. The study is open to adults aged 18 and older who have these tumors and cannot have them removed surgically. Participants will receive Lutathera through an IV every 8 weeks and take Olaparib pills twice a day. They will have regular check-ups, including scans and blood tests, to monitor their health and the treatment's effects.

Description

Neuroendocrine tumors (NETs) in the gastrointestinal tract and pancreas are rare but important to study. These tumors come from neuroendocrine cells and can be difficult to treat if they cannot be removed by surgery. This study is testing a combination of two drugs, Lutathera and Olaparib, to see if they can work together to shrink these tumors. Lutathera targets specific receptors on the tumor cells and delivers radiation to damage them, while Olaparib helps prevent the repair of damaged DNA in the cancer cells.

The study is divided into two phases. Phase I will focus on finding the safest dose of the drug combination, while Phase II will look at how well the treatment works in shrinking the tumors. Participants will receive Lutathera through an IV every 8 weeks for four cycles, and take Olaparib pills twice a day. They will have regular medical check-ups, including blood tests, scans, and heart function tests, to monitor their health and the treatment's effects.

Participants will have a follow-up visit about 4 weeks after the treatment ends, and then every 12 weeks for 3 years, followed by yearly phone calls to check on their health.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of neuroendocrine tumors in the pancreas or intestine that cannot be removed by surgery.
  • Must be 18 years or older.
  • Tumors must have somatostatin receptors, confirmed by a specific type of scan.
  • Must have a good overall health status, with an ECOG performance score of 0 or 1.
  • Must have normal organ and bone marrow function based on recent blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 7 months after.
  • Men must agree to use condoms during the study and for 4 months after, and not donate sperm during this time.

Exclusion Criteria

  • Tumors that do not show up on a specific type of scan unless they have been treated with other therapies and most tumors are visible on the scan.
  • Women who are breastfeeding must stop if participating in the study.
  • Other active cancers, except for certain skin cancers or cervical cancer that have been treated and not returned for 5 years.
  • Use of other investigational drugs or treatments within 4 weeks before the study.
  • Uncontrolled health conditions, such as heart failure or severe infections.
  • Active brain metastases that are not controlled.
  • Recent major surgery or inability to swallow pills.
  • Known allergies to the study drugs.
  • Certain heart conditions or blood disorders.
  • Active hepatitis or HIV infection.
  • Previous treatment with similar drugs or therapies.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.