Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NET

• Status: Completed
• Trial end date: 2017-06-07
• Target enrollment: 0
• Participant gender: All

Summary

The underlying hypothesis of the synergistic activity of octreotide and everolimus is based on the combination of a) a direct action of everolimus over mTOR (mammalian target of rapamycin), and b) the inhibitory effect of octreotide on the IGF-I (insulin like growth factor 1) system preventing the activation of the mTOR system by this factor. Both types of inhibition would completely cancel this signal transduction pathway, which is so important in neuroendocrine tumours.

Furthermore, the biological study proposed in this protocol will allow for better establishing the relationship between the activation of the IGFR-PI3K-mTOR signal transduction pathway (i.e., the mTOR pathway stimulated by IGFR) and treatment response; this information is relevant since the IGFR-PI3K-mTOR activation status could be a response prediction factor.

This study will provide significant additional information about the efficacy of the combination treatment of everolimus with octreotide LAR® in non-functioning GI NET.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Espanol de Tumores Neuroendocrinos
• Treatments: Everolimus; Octreotide; Sirolimus

Criteria

Inclusion Criteria:

• Diagnosis of non-operable or metastatic non-functioning, well differentiated advanced GI NET, confirmed by cytology or histology. In case of liver metastasis, neuroendocrine tumours of unknown origin are accepted.

• Confirmation of diagnosis of neuroendocrine carcinoma of low to intermediate histology grade

• Radiologically documented disease progression within 12 months prior to inclusion in the study. If the patient received anticancer treatment within the past 12 months, disease progression must be documented by radiology during or after taking this medication

• Adequate bone marrow. liver and renal function

Exclusion Criteria:

• Previous treatment with mTOR inhibitors (sirolimus, temsirolimus, everolimus, deforolimus).

• Patients with any serious disease and/or an uncontrolled clinical condition

• Patients on chronic treatment with corticosteroids or any other immunosuppressive agent