A multi-centre, randomised, parallel group, open-label, phase II, single-stage selection trial of nanoliposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (NEC)

The Christie NHS Foundation Trust0 sites58 target enrollmentSeptember 7, 2018

Conditionseuroendocrine carcinoma Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: euroendocrine carcinoma
Sponsor: The Christie NHS Foundation Trust
Enrollment: 58
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32029495 protocol (added 10/02/2020)

Registry

who.int

Start Date

September 7, 2018

End Date

October 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The Christie NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

•1\. Age \=18 years and life expectancy \>3 months
•2\. Diagnosed with poorly differentiated (as defined by the World Health Organisation in 2010, Ki 67 \>20%) extra\-pulmonary neuroendocrine carcinoma (NEC grade 3\). (Carcinoma of unknown primary is allowed if lung primary has been excluded)
•3\. Prior treatment with first\-line platinum\-based chemotherapy for NEC in the advanced setting and \=28 days from Day 1 of the previous treatment cycle
•4\. Documented radiological evidence of disease progression OR discontinuation of first\-line platinum\-based chemotherapy due to intolerance
•5\. Measurable disease according to RECIST 1\.1 (Appendix 1\)
•6\. Eastern Co\-operative Oncology Group (ECOG) performance status \=2 (see Appendix 2\)
•7\. Adequate renal function with serum creatinine \=1\.5 times upper limit of normal (ULN) and creatinine clearance \=50ml/min according to Cockroft\-Gault or Wright formula (see Appendix 3\)
•8\. Adequate haematological function: Hb \=90g/L, WBC \=3\.0 x 109/L, ANC \=1\.5 x 109/L, platelet count \=100 x 109/L
•9\. Adequate liver function: serum total bilirubin ?1\.5 x ULN (biliary drainage is allowed for biliary obstruction) and ALT and/or AST ?2\.5 x ULN in the absence of liver metastases, or ?5 x ULN in the presence of liver metastases
•10\. A negative pregnancy test is required at registration in women of childbearing potential

Exclusion Criteria

•Current participant exclusion criteria as of 25/11/2021:
•1\. Known or suspected allergy or hypersensitivity reaction to any of the components of study treatment or their excipients
•2\. Use (including self\-medication) within one week of randomisation and for the duration of the study of any of the following: St. John’s wort, grapefruit, Seville oranges, medicines known to inhibit UGT1A1 and medicines known to inhibit or induce either CYP3A4 or CYP3A5 (see Appendix 8 of protocol for list\*)
•3\. Previous treatment (for neuroendocrine carcinoma) with any of the components of combination chemotherapy regimens detailed in this study (nal\-IRI or 5\-FU or irinotecan or topoisomerase inhibitors or taxane\-based therapy)
•4\. Incomplete recovery from previous therapy in the opinion of the investigator (surgery/adjuvant therapy/radiotherapy/chemotherapy in advanced setting), including ongoing peripheral neuropathy of \> CTCAE grade 2 from previous platinum\-based therapy
•5\. Concurrent palliative radiotherapy involving target lesions used for this study (\< 28 days from discontinuation of radiotherapy). Radiotherapy for non\-target lesions is allowed if other target lesions are available outside the involved field
•6\. Patients must not have a history of other malignant diseases (within the previous 3 years, and there must be no evidence of recurrence), other than:
•6\.1\. Extra\-pulmonary neuroendocrine carcinoma
•6\.2\. Non\-melanoma skin cancer where treatment consisted of resection only or radiotherapy
•6\.3\. Ductal carcinoma in situ (DCIS) where treatment consisted of resection only