What side effects are associated with this type of intervention?

The most common treatments for pancreatic cancer, such as Sunitinib Malate and Lutetium Lu 177 Dotatate, have distinct side effect profiles. Sunitinib Malate often causes fatigue, diarrhea, nausea, hypertension, and hand-foot syndrome. Lutetium Lu 177 Dotatate is associated with nausea, vomiting, fatigue, and hematologic toxicities like thrombocytopenia, lymphopenia, anemia, and leukopenia. When combined, these treatments may lead to a cumulative side effect profile, including gastrointestinal disturbances, fatigue, and hematologic issues.

What prior FDA approvals exist?

For the treatment of pancreatic cancer, the FDA has approved several therapies. Sunitinib malate, a kinase inhibitor targeting VEGFRs, is approved for pancreatic neuroendocrine tumors (pNETs). Lutetium Lu 177 dotatate, a radioactive drug targeting somatostatin receptors, is also approved for treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including pNETs. These treatments focus on inhibiting tumor growth and delivering targeted radiation to cancer cells, respectively.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Pembrolizumab (an immune checkpoint inhibitor targeting PD-1) which has shown efficacy in various solid tumors including pancreatic cancer. 2) Lenvatinib combined with transarterial chemoembolization (TACE), which has demonstrated effectiveness in advanced hepatocellular carcinoma and may be applicable to pancreatic cancer. 3) Durvalumab (an immune checkpoint inhibitor targeting PD-L1) combined with chemotherapy, which has shown promise in advanced biliary tract cancer and could be considered for pancreatic cancer.

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Radioactive Drug

Sunitinib + Lutathera for Pancreatic Cancer

Phase 1

Recruiting

Led By Nikolaos Trikalinos

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Must not have

Patients with any of the following conditions are excluded: Serious or non-healing wound, ulcer, or bone fracture; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment; Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry; History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry; History of pulmonary embolism within the past 12 months; Class III or IV heart failure as defined by the New York Heart Association Class (NYHA) functional classification system; Patients receiving any medications or substances that are strong CYP3A4 inhibitors within 7 days before dosing, or strong CYP3A4 inducers within 12 days before dosing, are ineligible as sunitinib is a major substrate of CYP3A4. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible; Patients with uncontrolled intercurrent illness; Pregnant women are excluded from this study because sunitinib malate is an anti-angiogenic agent and lutetium Lu 177 dotatate is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib malate and lutetium Lu 177 dotatate, breastfeeding should be discontinued if the mother is treated with sunitinib malate and lutetium Lu 177 dotatate. Breastfeeding should be discontinued for 2.5 months following the last lutetium Lu 177 dotatate treatment. These potential risks may also apply to other agents used in this study; Patients who have had prior treatment with sunitinib malate or lutetium Lu 177 dotatate therapy or other radiopharmaceuticals (including, but not limited to, metaiodobenzylguanidine [MIBG], yttrium-90 [Y-90], radioactive iodide [RAI]), as MIBG and RAI could potentially increase risk of myelodysplastic syndrome or irreversible hematologic toxicities; Patients with left ventricular ejection fraction of 50% or less

History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate or lutetium Lu 177 dotatate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the time from first documentation of response (cr or pr) until the time of first documentation of disease progression by recist v1.1, assessed up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include risks from radiation exposure to normal cells despite targeted therapy; adverse reactions related to kinase inhibition such as high blood pressure; fatigue; digestive issues; skin problems; mouth sores; hand-foot syndrome; changes in hair color or loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hepatitis B is under control with treatment.

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I can take care of myself but might not be able to do heavy physical work.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My scans show I'm a candidate for a specific radioactive drug treatment.

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My pancreatic cancer is advanced and cannot be removed by surgery.

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I am 18 years old or older.

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My kidney function, measured by creatinine clearance or GFR, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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I am allergic to medications similar to sunitinib malate or lutetium Lu 177 dotatate.

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I can swallow and retain medication without issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the time from first documentation of response (cr or pr) until the time of first documentation of disease progression by recist v1.1, assessed up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the time from first documentation of response (cr or pr) until the time of first documentation of disease progression by recist v1.1, assessed up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and the time from first documentation of response (cr or pr) until the time of first documentation of disease progression by recist v1.1, assessed up to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Secondary study objectives

Chromogranin A levels

Duration of response

Intensity of tumor uptake

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (sunitinib malate, lutetium Lu 177 dotatate)Experimental Treatment6 Interventions

Patients receive sunitinib malate PO QD from day 1 of lutetium 177 dotatate therapy to 28 days after the last dose of lutetium 177 dotatate in the absence of unacceptable toxicity. Patients also receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Cycles repeat Q8W for 4 cycles in the absence of unacceptable toxicity. Patients undergo a CT scan and/or MRI throughout the trial. Patients also undergo a SSR PET/CT scan during screening and blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Sunitinib Malate

2008

Completed Phase 3

~3070

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sunitinib Malate and Lutetium Lu 177 Dotatate are two treatments for pancreatic cancer that work through targeted mechanisms. Sunitinib Malate is a kinase inhibitor that targets VEGFRs, reducing the blood supply to the tumor and inhibiting its growth. Lutetium Lu 177 Dotatate is a radioactive drug that targets somatostatin receptors on tumor cells, delivering radiation directly to the tumor and killing cancer cells while sparing normal cells. These targeted approaches are important for pancreatic cancer patients as they can improve treatment efficacy and reduce side effects compared to traditional chemotherapy.