A study to assess the schemas of retreatment with Lutathera® in patients with new progression of intestinal well-differentiated neuroendocrine tumor.

Phase 1

• Conditions: Patients with new progression of intestinal well-differentiated neuroendocrine tumor.; MedDRA version: 21.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001306-30-FR
• Lead Sponsor: Institut Régional du Cancer de Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

-Age = 18 years,
-Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),
-Patient previously treated with 4 cycles of Lutathera® (defined as First PRRT”),
-Disease control after First PRRT” = 12 months,
-Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT,
-Decision of retreatment with Lutathera® (defined as Second PRRT”) validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process,
-ECOG performance status 0-2,
-Life expectancy = 6 months as prognosticated by the physician,
-Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to randomization: (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (>= liver of surrounding tissue),
-Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with = 1 cm in longest diameter, and = 2 radiological tumors lesions in total,
-Adequate bone marrow reserve (Hb > 8 g/dl, neutrophils = 1500/mm³ and platelets = 80 000/mm³),
-Negative pregnancy test in women of childbearing potential (the ß-HCG dosage must be = 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),
-Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,
-Patient´s signed written informed consent,
-Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
-Affiliation to the French Social Security System.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patient who did not respond (no CR, PR or SD) to first PRRT”.
-Radiological progression after two cycles of Second PRRT” according to RECIST version 1.1,
-Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,
-Pancreatic NET,
-NeuroEndocrine Carcinoma,
-Prior external beam radiation therapy to more than 25% of the bone marrow,
-Severe renal (measured Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN or ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN),
-Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range,
-Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,
-Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,
-Hypertension that cannot be controlled despite medications (= 160/95 mmHg despite optimal medical therapy)
-Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),
-Pregnancy or breast feeding,
-Substance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results,
-Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,
-Concomitant participation or participation within the last 30 days in another clinical trial,
-History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.
-Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified