What side effects are associated with this type of intervention?

Common treatments for Neuroendocrine Tumors (NETs), such as Peptide Receptor Radionuclide Therapy (PRRT) with 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®), can lead to side effects including mild to moderate renal impairment, hematologic toxicity (e.g., myelodysplastic syndrome), and gastrointestinal symptoms. Somatostatin analogs like octreotide and lanreotide, often used in conjunction with PRRT, are generally well-tolerated but may cause gastrointestinal disturbances, gallstones, and alterations in glucose metabolism. Combining these therapies may enhance efficacy but also increases the risk of cumulative side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroendocrine Tumors (NETs) that target somatostatin receptors. One notable example is 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®), which is a peptide receptor radionuclide therapy (PRRT) that delivers targeted radiation to somatostatin receptor-positive gastroenteropancreatic NETs (GEP-NETs). Another approved treatment is lanreotide, a long-acting somatostatin analog, which has shown efficacy in controlling tumor growth in patients with unresectable, well- or moderately differentiated, locally advanced, or metastatic GEP-NETs. These therapies highlight the role of targeting somatostatin receptors in the management of NETs.

What other types of research exist?

Promising novel alternatives to 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) for treating Neuroendocrine Tumors (NETs) include: 1) Radiolabeled octreotide, specifically (90)Y-DOTA-Tyr(3)-octreotide (TOC), which has shown efficacy in reducing calcitonin levels and extending survival in patients with metastatic medullary thyroid cancer (MTC). 2) Lutetium Lu 177 vipivotide tetraxetan, which has demonstrated clinical efficacy in castration-resistant prostate cancer and is being explored for other NETs. 3) Ga-68 DOTATATE, Ga-68 DOTATOC, and Cu-64 DOTATATE PET/CT imaging agents, which are more sensitive than traditional somatostatin receptor scintigraphy and may aid in better targeting of therapies.

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Radiopharmaceutical

PRRT for Neuroendocrine Tumors

Phase 1

Recruiting

Led By Brendan C Visser, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan

Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only

Must not have

Known bone or peritoneal metastases

Prior 177Lu Dotatate treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial is testing a new treatment for patients with specific types of neuroendocrine tumors. The treatment aims to improve survival by targeting and killing cancer cells using radiation.

Who is the study for?

This trial is for adults with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have somatostatin receptors and are WHO Grade 1 or 2. Candidates must be fit for surgery aimed at removing most of the tumor, have not had certain treatments recently, and their major organs must function well.

What is being tested?

The study tests Peptide Receptor Radionuclide Therapy (PRRT) using Lutathera before and after surgical removal of tumors in patients with SSTR-positive GEP-NETs. It aims to see if this approach improves survival by combining imaging techniques like PET/CT, CT scans, and MRI.

What are the potential side effects?

Possible side effects include reactions to radioactive materials such as nausea, vomiting, fatigue; blood cell count changes leading to increased infection risk; kidney damage; liver toxicity; allergic reactions to contrast agents used in imaging.

Eligibility Criteria

Inclusion Criteria

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

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My scans show my cancer has somatostatin receptors.

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My cancer has spread to my liver or lymph nodes only.

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I am 18 years old or older.

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I have been on a stable dose of octreotide LAR for at least 12 weeks.

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I can carry out all my self-care but might not be able to do heavy physical work.

Exclusion Criteria

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

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My cancer has spread to my bones or abdomen.

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I have previously received 177Lu Dotatate treatment.

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I have cancer that has spread to my brain.

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I haven't had surgery, ablation, or certain radiation treatments affecting a lot of my bone marrow recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Transfusion-Free Surgery

Secondary study objectives

Overall Survival (OS)

Recurrence free Survival (RFS)

Response Rate (RR)

Side effects data

From 2021 Phase 3 trial • 231 Patients • NCT01578239

27%

Fatigue

19%

Abdominal pain

18%

Diarrhoea

13%

Abdominal distension

12%

Nausea

11%

Decreased appetite

10%

Back pain

10%

Arthralgia

Hypokalaemia

Hyperglycaemia

Flushing

Oedema peripheral

Dizziness

Dyspnoea

Vomiting

Gamma-glutamyltransferase increased

Insomnia

Aspartate aminotransferase increased

Weight decreased

Hypertension

Anaemia

Blood alkaline phosphatase increased

Cough

Asthenia

Alanine aminotransferase increased

Urinary tract infection

Dyspepsia

Anxiety

Palpitations

Constipation

Flatulence

Blood creatinine increased

Musculoskeletal pain

Pain in extremity

Headache

Hyponatraemia

Malignant neoplasm progression

Influenza like illness

Haematuria

Pyrexia

Blood bilirubin increased

Syncope

Lymphocyte count decreased

Platelet count decreased

Abdominal pain lower

General physical health deterioration

Abdominal pain upper

Alopecia

Small intestinal obstruction

Muscle spasms

Dysgeusia

Neoplasm progression

Thrombotic cerebral infarction

Pleural effusion

Non-small cell lung cancer

Haemorrhage intracranial

Hyperuricaemia

Breast cancer stage I

Carcinoid crisis

White blood cell count decreased

Arteriospasm coronary

Cardiac failure congestive

Duodenal obstruction

Gastrointestinal obstruction

Ileus

Impaired gastric emptying

Generalised oedema

Limb injury

Muscular weakness

Prostate cancer

Transient global amnesia

Acute kidney injury

Renal impairment

Cholecystitis acute

Anal haemorrhage

Ascites

Dehydration

Basal cell carcinoma

Malignant bowel obstruction

Oesophagitis

100%

80%

60%

40%

20%

Study treatment Arm

Octreotide LAR

177Lu-DOTA0-Tyr3-Octreotate

Trial Design

1Treatment groups

Experimental Treatment

Group I: LutatheraExperimental Treatment5 Interventions

2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lutathera

2022

N/A

~90

Magnetic Resonance Imaging (MRI)

2015

Completed Phase 4

~1800

Computed Tomography (CT)

2012

N/A

~100

PET/CT

2022

Completed Phase 3

~1300

0 / 9Eligibility 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

Peptide Receptor Radionuclide Therapy (PRRT) with 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) targets somatostatin receptors on neuroendocrine tumor cells by binding a radioactive compound to these receptors. This allows for direct delivery of radiation to the tumor cells, causing DNA damage and cell death while sparing surrounding healthy tissue. This targeted approach is significant for NET patients as it offers a treatment option that can effectively control tumor growth and improve quality of life with relatively few severe side effects. Other common treatments include somatostatin analogs, which inhibit hormone secretion and tumor growth, and everolimus, which inhibits the mTOR pathway to reduce cell proliferation. Each of these treatments leverages specific mechanisms to manage NETs, providing tailored therapeutic options based on tumor characteristics and patient needs.