Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

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Brief Title

Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

Official Title

Phase II Randomised Trial to Assess Progression of Carcinoid Heart Disease in Patients Treated With Lutathera Therapy Compared to Best Supportive Care.

Brief Summary

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

Detailed Description

      This is an open-label, phase II, multicentre, randomised (1:1) clinical trial of an
      interventional medicinal product. This study will open at 3 centres across the UK. King's
      College Hospital NHS Foundation Trust will act as the coordinating centre for the study.

      In this study, treatment with Lutathera will be compared to treatment with current best
      supportive care (somatostatin analogues) in patients with inoperable, somatostatin receptor
      positive, histologically confirmed small bowel NENs and these patients should have stable
      disease according to RECIST criteria for a period of 6 months prior to study entry.

      Patients on the treatment arm will receive four administrations of 7.4 GBq (200 mCi) of
      Lutathera (and concomitant amino acids will be given with each administration for kidney
      protection). Patients are scheduled to continue to receive study treatment until any of the
      following occurs:

        1. Unacceptable toxicity;

        2. Progressive disease as determined by RECIST Criteria;

        3. Inability or unwillingness of the patient to comply with study procedures;

        4. Patient withdraws consent to participate Patients on the best supportive care arm will
           receive somatostatin analogue treatment every 4 weeks according to local standard of
           care practices.

      Tumour response in both arms will be assessed after cycles 2 and 4 of 177Lu-Dotatate therapy,
      or every 16 weeks for patients enrolled under the best supportive care arm, according to
      RECIST criteria.

      The study population is comprised of patients with stable carcinoid heart disease (CHD) and
      carcinoid syndrome. King's College Hospital performed surgery on 30 patients with carcinoid
      heart disease over the last 5 years. On review of patient records at King's, a further 30
      patients with carcinoid heart disease were identified during the same time period who did not
      require surgery.

      Other centres participating in this study have similar populations of patients with CHD, with
      specific multi-disciplinary team meetings and outpatient clinics for identification and
      recruitment of suitable patients into the study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Change in NYHA heart failure score

Condition

Carcinoid Heart Disease

Intervention

Lutathera

Study Arms / Comparison Groups

 Lutathera Treatment Arm
Description:  • 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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

October 2020

Completion Date

December 2024

Primary Completion Date

November 2024

Eligibility Criteria

        Inclusion Criteria:

          1. Echocardiographic evidence of mild/ moderate carcinoid heart disease.

          2. Carcinoid syndrome with Echocardiographic evidence of carcinoid heart disease- to be
             defined further

          3. 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]

          4. Presence of metastasized or locally advanced, inoperable (curative intent)
             histologically proven, Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine
             (GEP-NET) or Lung-NET tumor

          5. Age >18

          6. Ki67 index ≤ 20%

          7. Patients who have provided a signed informed consent form to participate in the study,
             obtained prior to the start of any protocol related activities

          8. 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®).

        10. Irresectable disease 11. Karnofsky Performance Score (KPS) ≥60.

        Exclusion Criteria:

          1. Patients with progressive disease by RECIST progressed within 6 months

          2. Unable to consent

          3. Pregnant

          4. Chemotherapy within 3 months

          5. PRRT within 3 years

          6. Grade 3 tumours (WHO 2010)

          7. Severe or Uncontrolled carcinoid heart disease

          8. Renal impairment with eGRF <40 ml/min

          9. NYHA class III,IV
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04039516

Organization ID

263064


Responsible Party

Sponsor

Study Sponsor

King's College Hospital NHS Trust

Collaborators

 Advanced Accelerator Applications

Study Sponsor

, , 


Verification Date

August 2020