What is the mechanism of action of this treatment?

Lutetium-177 Octreotate (177Lu-DOTATATE) is a targeted radiation therapy that binds to somatostatin receptors, which are frequently overexpressed on Neuroendocrine Tumor (NET) cells. This binding allows for the direct delivery of radiation to the tumor cells, thereby minimizing damage to surrounding healthy tissues. This targeted approach is significant for NET patients as it offers a more precise treatment option with potentially fewer side effects compared to traditional chemotherapy, and it can improve progression-free survival and quality of life for those with somatostatin receptor-positive NETs.

What side effects are associated with this type of intervention?

Lutetium-177 Octreotate (Lu-DOTATATE) treatment for Neuroendocrine Tumors (NETs) commonly causes side effects such as nausea and hematologic toxicities, including thrombocytopenia, lymphopenia, anemia, and leukopenia. These side effects are typically mild and resolve within weeks, though serious adverse events like myelodysplastic syndrome and respiratory tract infections can occur but are rare. Overall, the treatment is well-tolerated with manageable side effects.

What prior FDA approvals exist?

The FDA has approved Lutetium-177 Dotatate (Lutathera) for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. This approval was largely based on the NETTER-1 trial, which demonstrated significant improvements in progression-free survival and quality of life for patients treated with Lutetium-177 Dotatate compared to high-dose octreotide LAR. The treatment involves four cycles of intravenous infusions, leveraging the targeted radiation therapy mechanism via somatostatin receptor binding.

What other types of research exist?

Promising novel alternatives to Lutetium-177 Octreotate for neuroendocrine tumors include: 1) Radiolabeled somatostatin analogs like Yttrium-90-DOTA-TOC, which has shown efficacy in reducing tumor markers and extending survival. 2) Systemic therapies such as Everolimus, which has demonstrated improved progression-free survival in neuroendocrine tumor patients. 3) Selective RET inhibitors like Selpercatinib and Pralsetinib, which are effective in RET-altered neuroendocrine tumors. 4) Combination therapies involving capecitabine and other chemotherapeutic agents, which have shown promise in clinical trials.

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Radioisotope Therapy

Lu-DOTATATE for Neuroendocrine Cancer

N/A

Waitlist Available

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Adequate liver function tests within 2 weeks prior to enrollment: total bilirubin ≤ 5 x ULN, ALT ≤ 5 x ULN, AST ≤ 5 x ULN, alkaline phosphatase ≤ 5 x ULN

Age ≥ 18 years

Must not have

Candidate for curative and/or debulking surgical resections

Radiotherapy to more than 25% of the bone marrow

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a targeted radiation therapy called Lutetium-177 Octreotate in patients with advanced neuroendocrine tumors that have specific receptors. The treatment aims to deliver radiation directly to the cancer cells to stop their growth. Patients will receive multiple treatment cycles, and their progress will be monitored over time. Lutetium-177 Octreotate was approved by the FDA in January 2018 for treating certain types of neuroendocrine tumors.

Who is the study for?

This trial is for adults over 18 with biopsy-proven neuroendocrine tumors, showing progression and positive for Somatostatin receptors. They should have an ECOG performance status ≤ 2, adequate organ function, no prior radionuclide therapy or certain other treatments within the last few weeks, and not be pregnant or breastfeeding.

What is being tested?

The study tests Lutetium-177 Octreotate's effectiveness in patients with neuroendocrine tumors who are Somatostatin receptor-positive. It involves four treatment cycles with possible dose adjustments based on individual responses and will compare progression-free survival at one year.

What are the potential side effects?

Potential side effects may include nausea, fatigue, kidney damage, blood cell count changes leading to increased infection risk or bleeding problems. Close monitoring of hematological reserve is required especially in patients with extensive bone metastases.

Eligibility Criteria

Inclusion Criteria

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

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My recent liver tests are within the normal range.

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I am 18 years old or older.

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

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My tumor is confirmed to be neuroendocrine through a biopsy.

Exclusion Criteria

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

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I am eligible for surgery to remove or reduce my cancer.

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I have received radiation therapy to a large portion of my bone marrow.

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I have another cancer that has worsened in the past 3 years.

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My diabetes is not under control.

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I have had treatment with radioactive drugs before.

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I do not have health issues like urinary incontinence that could affect my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Lutetium-177 OctreotateExperimental Treatment1 Intervention

Lutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks

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

Lutetium-177 Octreotate (177Lu-DOTATATE) is a targeted radiation therapy that binds to somatostatin receptors, which are frequently overexpressed on Neuroendocrine Tumor (NET) cells. This binding allows for the direct delivery of radiation to the tumor cells, thereby minimizing damage to surrounding healthy tissues. This targeted approach is significant for NET patients as it offers a more precise treatment option with potentially fewer side effects compared to traditional chemotherapy, and it can improve progression-free survival and quality of life for those with somatostatin receptor-positive NETs.