Sunitinib + Lutathera for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two treatments for patients with pancreatic tumors that can't be removed by surgery. One drug stops cancer cells from growing, and the other delivers radiation directly to the cancer cells to kill them. The goal is to find the safest and most effective dose.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take strong CYP3A4 inhibitors or inducers close to the start of the trial. It's important to discuss your current medications with the trial team to ensure there are no interactions.
Is the combination of Sunitinib and Lutathera safe for humans?
Sunitinib has been approved for use in certain types of cancer, including pancreatic neuroendocrine tumors, and common side effects include diarrhea, nausea, fatigue, and high blood pressure. Serious side effects can include heart problems. Lutathera is another treatment used for certain cancers, but specific safety data for the combination of Sunitinib and Lutathera is not provided in the available research.12345
How is the drug Sunitinib + Lutathera unique for treating pancreatic cancer?
The combination of Sunitinib and Lutathera is unique because it combines a targeted therapy (Sunitinib) with a radiopharmaceutical (Lutathera) that specifically targets somatostatin receptors, which are often present in pancreatic neuroendocrine tumors. This dual approach may offer a novel way to treat pancreatic cancer by both inhibiting tumor growth and delivering targeted radiation to cancer cells.678910
Who Is on the Research Team?
Nikolaos Trikalinos
Principal Investigator
Yale University Cancer Center LAO
Are You a Good Fit for This Trial?
Adults with well- or moderately-differentiated pancreatic neuroendocrine tumors that are metastatic/unresectable, who have had up to one line of systemic therapy (excluding somatostatin analogs), and can swallow pills. They must not be pregnant, agree to use contraception, and have adequate organ function. Excluded are those with certain heart conditions, uncontrolled illnesses, recent serious cardiovascular events, or prior treatment with similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive sunitinib malate orally daily and lutetium Lu 177 dotatate intravenously on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Optional continuation of treatment for further monitoring and assessment of long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium Lu 177 Dotatate
- Sunitinib Malate
Lutetium Lu 177 Dotatate is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor