Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors

Not Applicable

Active, not recruiting

• Conditions: Neuroendocrine Tumors

• Registration Number: NCT02743741
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-4-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Please note that only Ontario residents will be eligible for participation in this trial.<br><br>Inclusion Criteria:<br><br> 1. Biopsy-proven neuroendocrine tumor<br><br> 2. ECOG performance status = 2<br><br> 3. Ki-67 index = 30%<br><br> 4. Evidence of progressive disease demonstrated by imaging within six months prior to<br> study enrollment as defined by RECIST v1.1.<br><br> - Tumor board discussion of cases to confirm suitability for participation in the<br> clinical trial is required. Review should include but not limited to imaging<br> review, pathology (including Ki 67) and treatment options.<br><br> - Patients with objective evidence (imaging, or biochemical) that is insufficient<br> to be classified by RECIST 1.1 criteria can be eligible if after provincial<br> multidisciplinary tumor board discussion a consensus for progression<br> eligibility is reached.<br><br> - The tumor board would consider exemptions if the magnitude of change is<br> adequate by other definitions (e.g. using structural and contrast patterns and<br> biochemical changes).<br><br> - Where clinically indicated, formal consultation on pathology, diagnostic<br> imaging to facilitate criteria assessment (including 68Ga PET performed as part<br> of the diagnostic procedure) is strongly recommended.<br><br> 5. Adequate lab parameters within 2 weeks prior to enrollment:<br><br> - Serum creatinine = 150 µmol/L<br><br> - Calculated CrCl or measured GFR = 30 mL/min (measured GFR may be done within 4<br> weeks prior to enrollment)<br><br> - Haemoglobin = 90 g/L<br><br> - WBC = 2 x 109/L<br><br> - Platelets = 100 x 109/L<br><br> 6. Adequate liver function tests within 2 weeks prior to enrollment:<br><br> - total bilirubin = 5 x ULN<br><br> - ALT = 5 x ULN<br><br> - AST = 5 x ULN<br><br> - alkaline phosphatase = 5 x ULN<br><br> 7. Signed informed consent<br><br> 8. Patients with extensive bone metastases (e.g. >25% of bone marrow involvement are<br> eligible but requires careful monitoring of hematological reserve<br><br> 9. Subject's willingness and ability to comply with scheduled visits, treatment plans,<br> laboratory tests, and other study procedures.<br><br> 10. Age = 18 years.<br><br>Exclusion Criteria:<br><br> 1. Life expectancy <12 weeks<br><br> 2. An option for curative surgical or medical therapy or local liver embolization is<br> feasible<br><br> 3. Candidate for curative and/or debulking surgical resections<br><br> 4. Systemic, biologic, other radioisotope, embolization therapies within =4 weeks prior<br> to the first dose of 177Lu.<br><br> 5. Prior radiotherapy to target lesion(s) within =12 weeks prior to study enrollment<br> [radiotherapy to non-target lesions permitted].<br><br> 6. Prior therapy with any systemic radionuclide therapy.<br><br> 7. Radiotherapy to more than 25% of the bone marrow.<br><br> 8. Known brain metastases (unless metastases have been treated and are stable for = 6<br> months).<br><br> 9. Uncontrolled diabetes mellitus<br><br> 10. Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary<br> incontinence).<br><br> 11. Second cancer(s) with clinical or biochemical progression within the last 3 years.<br><br> 12. Pregnancy or breast feeding. Female subjects must be surgically sterile or<br> postmenopausal, or must agree to use effective contraception during the period of<br> therapy. All female subjects with reproductive potential must have a negative<br> pregnancy test (serum) prior to enrolment. Male subjects must be surgically sterile<br> or must agree to use effective contraception during the period of therapy. The<br> definition of effective contraception will be based on the judgment of the principal<br> investigator or a designated associate<br><br> 13. Other condition, illness, psychiatric condition, or laboratory abnormality that may<br> increase the risk associated with study participation, 68Ga or 177Lu administration,<br> or may interfere with the interpretation of study results and in the judgment of the<br> investigator would make the patient inappropriate for entry into this study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients progression-free using RECIST 1.1 criteria

Secondary Outcome Measures

Name	Time	Method
The overall response rate as determined by structural imaging using RECIST criteria.;The biochemical response rate (as defined by biochemical responses: serum chromogranin A and 24 hr urinary 5HIAA).;The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03;Overall survival;The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)