Lu-DOTA-TATE for Neuroendocrine Cancer

Overseen By David Laidely, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Must not be taking: Cytotoxic chemotherapy, mTOR inhibitors

Disqualifiers: Uncontrolled diabetes, Brain metastases, Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies per patient

66 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that certain treatments like surgery, radiation, or chemotherapy should not have been changed within 12 weeks before joining the trial.

What data supports the effectiveness of the treatment Lu-DOTA-TATE for neuroendocrine cancer?

Research shows that Lu-DOTA-TATE is effective in treating advanced neuroendocrine tumors, helping to slow disease progression and improve survival rates compared to other treatments like everolimus and sunitinib. It is particularly beneficial for patients with tumors that have progressed after initial treatments. ^{1 2 3 4 5}

Is Lu-DOTA-TATE safe for treating neuroendocrine cancer?

Lu-DOTA-TATE has been used in several studies for treating neuroendocrine tumors, and it is generally considered safe. Patients in these studies tolerated the treatment well, with no significant adverse effects reported. ^{4 5 6 7 8}

How is the treatment Lu-DOTA-TATE unique for neuroendocrine cancer?

Lu-DOTA-TATE is a unique treatment for neuroendocrine cancer because it is a type of peptide receptor radionuclide therapy (PRRT) that specifically targets somatostatin receptors, which are often overexpressed in these tumors. This treatment is used when the cancer progresses despite first-line treatments, offering a targeted approach that can improve survival and quality of life. ^{1 2 4 5 7}

What is the purpose of this trial?

Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as being effective in controlling symptoms and increase quality of life; induce stable disease and extend progression free survival; induce a (good) partial remission and induce a complete remission in patients with a somatostatin receptor positive tumour. The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE, and the quality of life of the patients treated with Lu-DOTA-TATE.

Research Team

David Laidley, MD

Principal Investigator

London Health Sciences Centre & Lawson Health Research Institute

Eligibility Criteria

This trial is for individuals aged 14-90 with somatostatin receptor positive tumors, who have a life expectancy of more than 26 weeks and good organ function. They must not be pregnant or breastfeeding, have uncontrolled diabetes, brain metastases unless stable for 6+ months, or had certain treatments within the last 12 weeks.

Inclusion Criteria

Provide written informed consent prior to enrollment.

My kidney function tests are within the required range.

I meet all the required criteria for secondary therapy in the study.

Exclusion Criteria

My blood sugar levels are not under control and are much higher than normal.

I haven't had major cancer treatments or changed my Sandostatin LAR dose in the last 12 weeks.

I am not eligible for Group B if I meet certain criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lu-DOTA-TATE (Lutetium-177 Octreotate) by intravenous infusion

Varies per patient

Multiple visits for infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 years

Regular follow-up visits

Treatment Details

Interventions

• Lu-DOTA-TATE

Trial Overview The study tests Lu-DOTA-TATE's effectiveness in patients with neuroendocrine carcinoma by observing how long they live without disease progression and overall survival. It also evaluates safety and quality of life impacts.

Participant Groups

Group I: Secondary Therapy with Lu-DOTA-TATE Experimental Treatment 1 Intervention

Patients who have received previous treatment with Lu-DOTA-TATE (Lutetium-177 Octreotate) under the special access program are eligible to be treated in this study. Patients will receive Lu-DOTA-TATE by intravenous infusion.

Group II: Primary Therapy with Lu-DOTA-TATE Experimental Treatment 1 Intervention

Lu-DOTA-TATE (Lutetium-177 Octreotate) will be administered by intravenous infusion to participants who have not been previously treated with Lu-DOTA-TATE

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Findings from Research

[177Lu]Lu-DOTA-TATE is an effective treatment for adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (NETs) who have not responded to first-line somatostatin analogs, addressing a critical need in advanced cases.

The treatment process for PRRT is complex but manageable, with care coordinators ensuring smooth communication and scheduling between primary oncologists and specialists, which is essential for patient care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for the Coordinated Care of Patients With Neuroendocrine Tumors Undergoing Peptide Receptor Radionuclide Therapy. Hendifar, AE., Mehr, SH., McHaffie, DR.[2023]

177Lu-DOTA-TATE therapy is highly effective for treating metastatic, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (NETs), with mostly tolerable side effects.

This therapy is typically used as a second-line treatment after somatostatin analogs (SSA) for gastroenteric NETs and as a second or third-line option for pancreatic NETs, potentially improving survival rates and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastro-Enteric-Pancreatic Neuroendocrine Tumor Treatment: 177Lu-DOTATATE. Sanli, Y., Denizmen, D., Subramaniam, RM.[2023]

In a study of 36 patients with gastroenteropancreatic neuroendocrine tumors treated with 177Lu-DOTA-TATE, 71.4% experienced symptomatic improvement, and the median overall survival was 121.7 months, indicating significant efficacy of the treatment.

The therapy was found to be safe, with only 8.9% of treatment cycles resulting in acute side effects and no significant renal or hematologic toxicity, while higher expression of somatostatin receptors correlated with better survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of Gastroenteropancreatic Neuroendocrine Tumors with 177Lu-DOTA-TATE: Experience of the Portuguese Institute of Oncology in Porto]. Sampaio, IL., Luiz, HV., Violante, LS., et al.[2019]

In a study of 79 patients with progressive neuroendocrine tumors treated with Lu-DOTATATE, 13% showed a partial response and 64% had stable disease, with a median time to progression of 28 months overall.

The treatment was found to be safe, with only a few patients experiencing mild toxicity, including grade 1 haematotoxicity and nephrotoxicity, supporting its use as an effective option for managing these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET. Pencharz, D., Walker, M., Yalchin, M., et al.[2019]

The guideline for treating neuroendocrine tumors with Lu-177-DOTA-TATE emphasizes radiation safety and has been approved by the Japanese Society of Nuclear Medicine, ensuring a standardized approach in Japan.

While specific to Japan, the radiation protection issues addressed in this guideline are relevant and beneficial for international practices in the treatment of neuroendocrine tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual on the proper use of lutetium-177-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable in radionuclide therapy (2nd ed.). Hosono, M., Ikebuchi, H., Nakamura, Y., et al.[2018]

The pilot study involving 4 patients with advanced neuroendocrine neoplasms (NEN) showed that a single low dose of 177Lu-DOTA-EB-TATE was well-tolerated without significant adverse effects, leading to symptomatic remission in all patients.

177Lu-DOTA-EB-TATE demonstrated a significant reduction in tumor uptake (SUVmax) in 72.5% of tumors, indicating its efficacy, and it achieved similar results to the higher dose of 177Lu-DOTA-TATE therapy, suggesting potential advantages for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to Single Low-dose 177Lu-DOTA-EB-TATE Treatment in Patients with Advanced Neuroendocrine Neoplasm: A Prospective Pilot Study. Wang, H., Cheng, Y., Zhang, J., et al.[2019]

The optimized protocol for preparing (177)Lu-DOTA-TATE allows for high specific activity and radiochemical purity, achieving a purity of 98.25% and specific activity ranging from 32.74 to 65.49 GBq/μmol across 100 batches prepared in India.

This method has successfully facilitated the administration of 250 patient doses to 150 individuals with inoperable neuroendocrine tumors, highlighting its potential efficacy as a treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of patient doses of (177)Lu-DOTA-TATE using indigenously produced (177)Lu: the Indian experience. Das, T., Chakraborty, S., Kallur, KG., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Best Practices for the Coordinated Care of Patients With Neuroendocrine Tumors Undergoing Peptide Receptor Radionuclide Therapy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Gastro-Enteric-Pancreatic Neuroendocrine Tumor Treatment: 177Lu-DOTATATE. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Matching-adjusted indirect treatment comparison of [177Lu]Lu-DOTA-TATE, everolimus and sunitinib in advanced, unresectable gastroenteropancreatic neuroendocrine tumours: Relative effectiveness of [177Lu]Lu-DOTA-TATE in gastroenteropancreatic neuroendocrine tumours. [2021]

4. Portugal pubmed.ncbi.nlm.nih.gov

[Treatment of Gastroenteropancreatic Neuroendocrine Tumors with 177Lu-DOTA-TATE: Experience of the Portuguese Institute of Oncology in Porto]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET. [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

Manual on the proper use of lutetium-177-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable in radionuclide therapy (2nd ed.). [2018]

7. Australia pubmed.ncbi.nlm.nih.gov

Response to Single Low-dose 177Lu-DOTA-EB-TATE Treatment in Patients with Advanced Neuroendocrine Neoplasm: A Prospective Pilot Study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Preparation of patient doses of (177)Lu-DOTA-TATE using indigenously produced (177)Lu: the Indian experience. [2019]