Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
This research is looking into a new way to treat pancreatic neuroendocrine tumours that have spread or cannot be removed by surgery. We are testing a combination of two medicines: sunitinib malate and lutetium Lu 177 dotatate (also known as Lutathera). Sunitinib malate works by targeting and blocking specific signals that help cancer cells grow, while lutetium Lu 177 dotatate is a 'smart bomb' type of radiation that travels directly to tumour cells, trying to kill them without harming too many healthy cells. The main goal is to find out if this combination is safe, what the best dose is, and if it can shrink tumours or stop them from growing. This is an early-stage study, meaning we are still exploring the treatment's safety and how well it works.
At a glance
What is this study about?
This study focuses on a type of cancer called pancreatic neuroendocrine tumours, specifically when they have spread to other parts of the body (metastatic) or when surgery isn't an option. These tumours develop from special cells in the pancreas. The researchers want to see if combining two existing treatments might work better than using them alone.
One of the treatments is called sunitinib malate. This medicine works by targeting specific proteins in cancer cells that help them grow and multiply. By blocking these proteins, sunitinib malate aims to slow down or stop the tumour's growth. The other treatment is lutetium Lu 177 dotatate, often known as Lutathera. This is a type of 'radioactive' medicine, but it's very clever. It's designed to attach itself to specific spots, called 'receptors', on the surface of neuroendocrine tumour cells. Once attached, it delivers a small dose of radiation directly to the tumour cells, aiming to kill them while largely sparing healthy tissues.
The idea behind this study is that by combining these two different approaches – one that targets growth signals and one that delivers radiation directly to the tumour cells – they might be more effective together in shrinking these tumours or stopping them from growing. This is a Phase 1 study, which means the main aim is to check the safety of giving these two drugs together, find the right dose, and understand any side effects, before moving on to larger studies.
Key takeaways
- Tests a new combination of two existing cancer drugs for advanced pancreatic neuroendocrine tumours.
- Aims to check the safety and best dose of sunitinib malate with lutetium Lu 177 dotatate.
- Sunitinib blocks cancer growth signals; lutetium Lu 177 dotatate delivers targeted radiation.
- Participation involves daily tablets, intravenous treatment every 8 weeks, and regular scans/blood tests.
- This is an early-stage (Phase 1) study looking for better treatment options.
- Careful monitoring for side effects is a key part of the trial.
Who may be eligible?
To join this study, you must have a confirmed diagnosis of pancreatic neuroendocrine tumours that have spread or cannot be removed by surgery. Your tumour needs to be 'well-differentiated' or 'moderately-differentiated', meaning it's not a very fast-growing type. You must also be at least 18 years old.
The doctors will check scans to make sure your tumours have certain markers that make them suitable for one of the study drugs. You might have had some previous treatments, but there are specific rules about how many and how recently. For example, if you've had previous systemic therapy for advanced disease, your cancer must have shown signs of getting worse within the last 12 months. Your general health and organ function (like kidneys, liver, and blood counts) will also be checked to make sure it's safe for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do you have a confirmed advanced pancreatic neuroendocrine tumour?
- Are you at least 18 years old?
- Are your tumours the 'well-differentiated' or 'moderately-differentiated' type?
- Have you had recent scans showing your tumour has the right markers for one of the drugs?
- Is your general health (like blood counts, kidney, and liver function) generally good?
- Are you able to attend regular hospital appointments for treatment and tests?
What does participation involve?
If you decide to take part, you will receive sunitinib malate as tablets every day, alongside lutetium Lu 177 dotatate given into your vein (intravenously) over about 30 minutes on the first day of each cycle. A treatment cycle lasts 8 weeks, and you would receive up to 4 cycles in total, as long as you're not experiencing difficult side effects.
Throughout the study, you'll have regular hospital visits for assessments. This will include blood tests to check your general health and how the treatment is affecting you. You'll also have scans like CT scans or MRI scans to see how the tumour is responding, and a special type of PET scan (SSR PET/CT) will be done at the beginning. The study also involves collecting blood samples for further research. After your treatment finishes, you'll be followed up for about 4 weeks to monitor your health.
Potential risks and benefits
Locations (10)
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States· Active not recruiting
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareVerified postcodeIrvine, United States· Recruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterVerified postcodeOrange, United States· Recruiting
- Memorial Hospital EastVerified postcodeShiloh, United States· Recruiting
- Siteman Cancer Center at Saint Peters HospitalVerified postcodeCity of Saint Peters, United States· Recruiting
- Siteman Cancer Center at West County HospitalVerified postcodeCreve Coeur, United States· Recruiting
- Washington University School of MedicineVerified postcodeSt Louis, United States· Recruiting
- Siteman Cancer Center-South CountyVerified postcodeSt Louis, United States· Recruiting
- Siteman Cancer Center at Christian HospitalVerified postcodeSt Louis, United States· Recruiting
- University Health Network-Princess Margaret HospitalVerified postcodeToronto, Canada· Active not recruiting
Common questions
What is a pancreatic neuroendocrine tumour?
It's a rare type of cancer that starts in special hormone-producing cells in your pancreas.
What does 'metastatic' mean?
It means the cancer has spread from where it started to other parts of your body.
What is a Phase 1 trial?
It's the first stage of testing a new treatment combination in people, mainly to check if it's safe and to find the right dose.
Will I get both medications?
Yes, if you join this study, you will receive both sunitinib malate and lutetium Lu 177 dotatate.
What are 'targeted therapies'?
These are treatments that specifically attack cancer cells by targeting specific features, rather than affecting all cells like traditional chemotherapy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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