SEQTOR

• Research type

  Research Study

• Full title

  Randomized open label study to compare the efficacy and safety of everolimus followed by chemotherapy with STZ-5FU upon progression or the reverse sequence, chemotherapy with STZ-5FU followed by everolimus upon progression, in advanced progressive pNETs (SEQTOR study)

• IRAS ID

  153571

• Contact name

  Nicolas Reed

• Sponsor organisation

  Grupo Español de Tumores Neuroendocrinos (GETNE)

• Eudract number

  2013-000726-66

• Duration of Study in the UK

  4 years, 5 months, 29 days

• Research summary

  This study is a randomised open label cross-over study designed to compare the safety and efficacy of the sequence in which two therapies are given to patients suffering from advanced progressive pancreatic Neuroendocrine tumours (pNETs).

  Streptozotocin (STZ) based chemotherapy, STZ with 5-FU, is the standard of care for advanced pNETS in the European Union while everolimus, an inhibitor of tumoral cell growth, has been recently approved in the USA and Europe.

  The study will be conducted in approximately 8 European countries. Around 180 patients who meet the inclusion criteria, and to whom none of the exclusion criteria apply will be recruited.

  The recommended dose for everolimus is 10 mg once a day while a clinical benefit is observed or until unacceptable toxicity occurs. The length of cycles is 4 weeks (28 days).

  STZ-5FU treatment is administered as STZ 0.5 g/m2 on days 1 – 5 and 5-FU as 400 mg/m2 days on days 1 – 5 every 6 weeks (Moertel) or, as 0.5 g/m2 STZ on days 1 – 5 and 400 mg/m2 5-FU on days 1-3 and then 1-day treatment with 1 g/m2 STZ and 1 day treatment with 400mg/m2 5-FU every 3 weeks (Uppsala).

  At disease progression the patients will cease the first treatment, undergo a resting period of up to 4 weeks from their last dose and then commence the second treatment if they remain eligible. The second treatment will continue until second progression or at 84 weeks. There will be a follow-up visit 30 days after the last dose.

  Tumour blocks and blood samples will be donated for research. Blood and urine samples will be taken for safety and efficacy. X-rays/CT will obtained. Tumour lesions will be assessed by RECIST.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  14/LO/1638

• Date of REC Opinion

  19 Dec 2014

• REC opinion

  Further Information Favourable Opinion