An Open Label Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients with Somatostatin Receptor Positive Tumours

NCT02236910 | Unknown Phase 2

• 2 other identifiers: TX-LUT-001-LondonLu-DOTA-TATE
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroendocrine Carcinoma

Keywords

somatostatin receptor positive tumour

Outcome Measures

Primary Outcomes (1)

• Tumour response measured by RECIST criteria

  Target lesions will be assigned after treatment 1 base done either the Lu-177 scan, or the CT/MRI scan within 2 weeks prior to treatment 1. Tumour response will be measured using response evaluation criteria in solid tumours (RECIST).

  7 years (end of study)

Secondary Outcomes (2)

• Progression Free Survival

  7 years (end of study)

• Quality of Life Response Changes

  7 years (end of study)

Study Arms (2)

Primary Therapy with Lu-DOTA-TATE

EXPERIMENTAL

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

Other: Lu-DOTA-TATE

Secondary Therapy with Lu-DOTA-TATE

EXPERIMENTAL

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.

Other: Lu-DOTA-TATE

Interventions

Lu-DOTA-TATE OTHER

Also known as: Lutetium-177 Octreotate, radiopharmaceutical

Primary Therapy with Lu-DOTA-TATE; Secondary Therapy with Lu-DOTA-TATE

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Group A: Primary therapy subjects will be included in the study if they meet all of the following general criteria:
• Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
• Presence of somatostatin receptor positive tumour(s) (either histologically or Octreoscan image proven), with at least 1 tumour site reliably evaluable by CT or MRI of at least 1.5 cm (smallest dimension) with respect to RECIST criteria (the target lesion).
• Presence of somatostatin receptors on (at least) the target lesion demonstrated by uptake of OctreoScan® at least equal to liver uptake within 12 weeks of enrollment.
• Life expectancy greater than 26 weeks from enrollment.
• Serum creatinine ≤ 130 μmol/L, and a measured glomerular filtration rate (GFR) using plasma clearance of ≥50 mL/min measured within 2 weeks of enrollment.
• Haemoglobin concentration ≥ 90 g/L; white blood cell count (WBC) ≥ 3 x 109/L; platelets ≥ 100 x 109/L measured within 2 weeks of enrollment.
• Liver function tests (serum albumin, total bilirubin, alanine amniotransferase (ALT),aspartate aminotransferase (AST) and alkaline phosphatase) ≤ 3 X the limit of normal.
• Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrollment.
• Provide written informed consent prior to enrollment.
• Ki 67 \< 20%, unless patients has been treated with chemotherapy and lesions are stable (Ki 67 \< 30%)
• Group B: Secondary therapy subjects will be included in the study if they meet all of the following general criteria:
• Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
• Have received Lu-DOTA-TATE treatment at the London Health Sciences Centre under the Special Access Programed or other radionuclide therapy for neuroendocrine tumor.
• Provide written informed consent prior to enrollment.

You may not qualify if:

• Group A: Primary therapy subjects will be excluded from the study if they meet any of the following criteria:
• Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
• Surgery, radiation therapy, radioisotope therapy, change in Sandostatin LAR therapy dosage, cytotoxic chemotherapy, embolization or other investigative therapy \[interferons, mammalian target of rapamycin (mTOR) inhibitors\] within 12 weeks of enrollment. Localized external beam irradiation permitted as long as target lesion unaffected.
• Known brain metastases unless these metastases have been treated or stable (confirmed by CT) for ≥ 6 months prior to enrollment
• Uncontrolled diabetes mellitus defined as fasting glucose ≥ 3 X the upper limit of normal within 12 weeks of enrollment.
• Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
• Pregnancy.
• Breast feeding.
• Prior radiation therapy to more than 25% of the bone marrow.
• Group B: Secondary therapy subjects will be excluded from the study if they meet any of the following criteria:
• Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
• Pregnancy.
• Breast feeding.

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Swiha MM, Sutherland DEK, Sistani G, Khatami A, Abazid RM, Mujoomdar A, Wiseman DP, Romsa JG, Reid RH, Laidley DT. Survival predictors of 177Lu-Dotatate peptide receptor radionuclide therapy (PRRT) in patients with progressive well-differentiated neuroendocrine tumors (NETS). J Cancer Res Clin Oncol. 2022 Jan;148(1):225-236. doi: 10.1007/s00432-021-03672-w. Epub 2021 Jun 10.

  PMID: 34110489 DERIVED

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

lutetium Lu 177 dotatate; Radiopharmaceuticals

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals

Study Officials

• david laidley, MD

  London Health Sciences Centre & Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2023-10

Locations

CA (1)