Lu-DOTA-TATE for Neuroendocrine Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDavid Laidley, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

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

No Placebo Group

Prior Safety Data

Trial Summary

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.

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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.

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Treatment Details

Interventions

Lu-DOTA-TATE (Radiopharmaceutical)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Secondary Therapy with Lu-DOTA-TATEExperimental Treatment1 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-TATEExperimental Treatment1 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