Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

NCT04039516 | Unknown Phase 2 DMC

• 1 other identifier: 263064
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomised trial to assess progression of carcinoid heart disease in patients treated with Lutathera therapy compared to best supportive care.

Conditions

Carcinoid Heart Disease; Carcinoid Syndrome; Carcinoid Tumor

Outcome Measures

Primary Outcomes (1)

• The rate of progression of moderate carcinoid heart disease (CHD)

  The rate of progression of carcinoid heart disease (CHD) in patients with moderate CHD will be compared across the Lutathera Therapy and Best Supportive Care Arms and will be assessed through RECIST CT/MRI imaging and urinary 5-HIAA levels throughout the duration of the study. The rate of progression will be assessed at each study visit across both arms during the intervention and follow-up phase. If the study treatment is successful in delaying the rate of progression, then the rate of progression in the Lutathera (study intervention) arm is expected to be much slower than in the Best Supportive Care arm.

  5 years

Secondary Outcomes (4)

• Change in NYHA heart failure score

  5 years

• Progressive disease

  5 years

• Reduction in urinary 5-HIAA levels

  5 years

• Change in quality of life measurements (European Organization for Research and Treatment of Cancer questionnaires, QLQ-C30 and QLQ-GI.NET2)

  5 years

Study Arms (2)

Lutathera Treatment Arm

EXPERIMENTAL

• 4x cycles of 7.4 GBq (200mCi) of Lutathera therapy (177Lu-DOTA0-Tyr3-Octreotate) with concomitant amino acids for participants randomised onto the Lutathera therapy arm, every 8 weeks, plus long term somatostatin analogues (SSTA).

Drug: Lutathera

Best Supportive Care

NO INTERVENTION

Somatostatin analogue treatment according to current standard, routine care

Interventions

Lutathera DRUG

A total of 4 infusions of Lutathera to be administered every 8 weeks.

Lutathera Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Echocardiographic evidence of mild/ moderate carcinoid heart disease.
• Carcinoid syndrome with Echocardiographic evidence of carcinoid heart disease- to be defined further
• Elevated urinary 5-HIAA or NYHA class I or II on therapy \[not necessarily exceeding label dose of SSA LAR; eg, could be 30mg SMS LAR plus sc SMS for breakthrough\]
• Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine (GEP-NET) or Lung-NET tumor
• Age \>18
• Ki67 index ≤ 20%
• Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities
• Confirmed presence of somatostatin receptors on all target lesions documented by CT/MRI scans, within 8 weeks prior to randomization (centrally confirmed), as assessed by the following somatostatin receptor imaging (SRI) modalities: \[68Ga\]-DOTA-TOC (Somakit-TOC™) PET/CT imaging or \[68Ga\]-DOTA-TATE PET/CT imaging (NETSPOTTM) or Somatostatin Receptor scintigraphy (SRS) with 111In-pentetreotide (Octreoscan®).
• \. Irresectable disease 11. Karnofsky Performance Score (KPS) ≥60.

You may not qualify if:

• Patients with progressive disease by RECIST progressed within 6 months
• Unable to consent
• Pregnant
• Chemotherapy within 3 months
• PRRT within 3 years
• Grade 3 tumours (WHO 2010)
• Severe or Uncontrolled carcinoid heart disease
• Renal impairment with eGRF \<40 ml/min
• NYHA class III,IV

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Advanced Accelerator Applications: collaborator

MeSH Terms

Conditions

Carcinoid Heart Disease; Serotonin Syndrome; Carcinoid Tumor

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Malignant Carcinoid Syndrome; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Heart Diseases; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

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

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 31, 2019
• Study Start: October 1, 2020
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share