Overview

Efficacy and Safety of Everolimus and (STZ-5FU) Given One Upfront the Other Upon Progression in Advanced Pancreatic Neuroendocrin Tumor (pNET)

Status:
Active, not recruiting
Trial end date:
2021-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare STZ vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of streptozotocin (STZ) based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Grupo Espanol de Tumores Neuroendocrinos
Collaborators:
European Neuroendocrine Tumor Society
Kantar Health
Novartis Pharmaceuticals
Treatments:
Everolimus
Fluorouracil
Sirolimus
Criteria
Inclusion Criteria:

- Histologically proven diagnosis of unresectable or metastatic, advanced pancreatic
NET.

- Documented confirmation of pancreatic NET G1 or G2 as per European Neuroendocrine
Society (ENETS) classification system.

- Patients from whom a paraffin-embedded primary tumour or metastasis block is available
and to be sent by Courier.

- Before study inclusion, patients must show progressive disease documented by radiology
12 months prior to study inclusion. Treatment naive patients can be also included if
the patient needs active treatment with either chemotherapy or everolimus.

- Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors
(RECIST) criteria 1.0, documented by a Triphasic Computed Tomography (CT) scan or
multiphase MRI radiological assessment.

- Previous treatment with somatostatin (SS) analogues is allowed. Only those patients
with active functioning syndrome at entry can continue with SS analogues during the
study.

- Adequate bone marrow and renal functions, and serum fasting cholesterol

- Women with child-bearing potential must have a negative serum pregnancy test.

- Written Informed Consent obtained according to local regulations

Exclusion Criteria:

- Previous treatment with chemotherapy and/or mTOR inhibitors or tyrosine kinase
inhibitors.

- Immune therapy or radiation therapy within 4 weeks prior to the patient entering the
study.

- Hepatic artery embolization within the last 6 months (1 month if there are other sites
of measurable disease), or cryoablation/radiofrequency ablation of hepatic metastasis
within 2 months of enrolment.

- Previous treatment with Peptide-Receptor Radionuclide Therapy (PRRT) within the last 6
months and/or without progression following PRRT.

- Uncontrolled diabetes mellitus.

- Any severe and/or uncontrolled medical conditions.

- Treatment with potent inhibitors or inducers of Cytochrome P450 3A4 (CYP3A) isoenzyme
within 5 days immediately before the start of treatment.

- Patients on chronic treatment with corticosteroids or any other immunosuppressive
agent.

- Patients known to be HIV seropositive.

- Known intolerance or hypersensitivity to everolimus or its excipients or other
rapamycin analogues. Patients with rare hereditary problems of galactose intolerance,
Lapp lactase deficiency or glucose-galactose malabsorption should not take this
medicinal product.

- Known intolerance or hypersensitivity to 5FU or STZ or its excipients (notice that
this criterion includes patients with known deficit of dihydropyrimidine dehydrogenase
deficiency -DPD).

- Pregnant, lactating women or fertile adults not using effective birth control methods.

- For administrative matters (insurance) patients ≥ 95 are not allowed during the trial.

Only those patients coming from the hospital pool will be included in SEQTOR trial (e.g.
persons detained in an institution as a result of an official or court order are excluded).