24 Participants Needed

Sunitinib + Lutathera for Pancreatic Cancer

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

What data supports the effectiveness of the drug Sunitinib in treating pancreatic cancer?

Sunitinib has shown effectiveness in treating advanced pancreatic neuroendocrine tumors, and it can make pancreatic cancer more sensitive to radiation therapy, which may help in its treatment.2451112

Who Is on the Research Team?

Nikolaos Trikalinos, MD - Washington ...

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

My hepatitis B is under control with treatment.
I can take care of myself but might not be able to do heavy physical work.
My heart function is classified as class 2B or better according to the NYHA.
See 18 more

Exclusion Criteria

You are currently taking any other experimental medications.
You cannot participate if you have certain health conditions like serious wounds, history of specific heart or blood vessel issues, uncontrolled illness, or if you are pregnant or breastfeeding.
I am allergic to medications similar to sunitinib malate or lutetium Lu 177 dotatate.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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.

32 weeks
4 visits (in-person) for lutetium Lu 177 dotatate administration, additional visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Extension

Optional continuation of treatment for further monitoring and assessment of long-term outcomes

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Lutetium Lu 177 Dotatate
  • Sunitinib Malate
Trial Overview The trial is testing the combination of Sunitinib Malate (a kinase inhibitor) and Lutetium Lu 177 Dotatate (a radioactive drug targeting tumor cells) for safety and effectiveness in treating pancreatic neuroendocrine tumors. It's a phase I study determining the best dose while monitoring side effects.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (sunitinib malate, lutetium Lu 177 dotatate)Experimental Treatment6 Interventions

Lutetium Lu 177 Dotatate is already approved in European Union, United States for the following indications:

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Approved in European Union as Lutathera for:
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Approved in United States as Lutathera for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a phase II study involving 47 patients with advanced non-small cell lung cancer (NSCLC), sunitinib showed a low objective response rate of 2.1%, but 23.4% of patients experienced stable disease for at least 8 weeks, indicating some potential for disease control.
The treatment was generally well tolerated, with a median progression-free survival of 11.9 weeks and a median overall survival of 37.1 weeks, suggesting that sunitinib may be a viable option for patients who have not responded to platinum-based chemotherapy.
Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer.Novello, S., Scagliotti, GV., Rosell, R., et al.[2021]
Sunitinib malate is a multi-kinase inhibitor approved for treating advanced renal cell carcinoma and other specific tumors, showing modest antitumor activity in ovarian cancer based on Phase I and II trials.
The drug has an acceptable safety profile, but further research is needed to better understand its toxicity and to explore combination therapies for enhanced efficacy.
The potential of sunitinib as a therapy in ovarian cancer.Leone Roberti Maggiore, U., Valenzano Menada, M., Venturini, PL., et al.[2018]
Sunitinib malate is an oral medication that inhibits key pathways involved in tumor growth and blood vessel formation, making it a potential treatment for metastatic breast cancer.
In a report involving four patients with advanced breast cancer, combining sunitinib with docetaxel chemotherapy led to clinically meaningful responses, suggesting that this combination may enhance treatment efficacy.
Early experience with sunitinib, combined with docetaxel, in patients with metastatic breast cancer.Liljegren, A., Bergh, J., Castany, R.[2018]

Citations

Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. [2021]
The potential of sunitinib as a therapy in ovarian cancer. [2018]
Early experience with sunitinib, combined with docetaxel, in patients with metastatic breast cancer. [2018]
Targeting VEGF-VEGFR Pathway by Sunitinib in Peripheral Primitive Neuroectodermal Tumor, Paraganglioma and Epithelioid Hemangioendothelioma: Three Case Reports. [2022]
SU11248 (sunitinib) sensitizes pancreatic cancer to the cytotoxic effects of ionizing radiation. [2022]
FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors. [2021]
Assessment of the safety and efficiency of sunitinib malate in metastatic neuroendocrine tumours of the pancreas (NEN G1/G2) depending on the number and type of earlier therapeutic lines - initial report. [2018]
Phase I study of the 177Lu-DOTA0-Tyr3-Octreotate (lutathera) in combination with nivolumab in patients with neuroendocrine tumors of the lung. [2021]
177Lu-Dotatate administration using an infusion pump or a peristaltic pump: comparison of two methods. [2022]
Efficacy and safety of 177Lu‑DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study. [2022]
Lutathera® Orphans: State of the Art and Future Application of Radioligand Therapy with 177Lu-DOTATATE. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Patient Release and Instructions for Lutetium Dotatate Radiopharmaceutical Therapy. [2023]
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