Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma (G3) with a Ki67 of 20-55%

Dept of Oncology. Haukeland University Hospital0 sites40 target enrollmentSeptember 19, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma (G3) with a Ki67 of 20-55%
Sponsor: Dept of Oncology. Haukeland University Hospital
Enrollment: 40
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

September 19, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Dept of Oncology. Haukeland University Hospital

•Histology and staging disease:
•Histologically proven neuroendocrine carcinoma with a Ki67 of 20\-55% by local pathology review.
•Primary gastrointestinal tumor or cancer of unknown primary when metastases are mainly GI.
•The patient cannot by surgery be rendered free from disease
•General conditions:
•\>18 years;
•WHO performance status 1\.
•Adequate haematological function
•Adequate renal and hepatic functions:
•Written informed consent prior to inclusion must be obtained and documented according to the local regulatory requirements

•Prior chemotherapy for advanced/metastatic disease.
•Adjuvant chemotherapy must have ended \> 6 months before inclusion.
•Patients with known hypersensitivity to temozolamide, dacarbacine, everolimus or other mTOR inhibitors.
•Female patients who are pregnant or breastfeeding or adults of reproductive potential who are not using effective birth control methods. Acceptable contraceptive methods should be used by both sexes throughout the period of study treatment and continued for at least 8 weeks after termination of treatment.
•Other anti\-cancer systemic treatment within the last 8 weeks, including other experimental drugs.
•Chronic infectious or immunosuppressive disease including, but not limited to, HIV, HCV and HBV.
•Uncontrolled diabetes mellitus defined as HbA1c \= 8% despite adequate therapy.
•Known hypersensitivity to temozolomide or everolimus, or related compounds.
•Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents.
•Other serious medical condition or illness that according to the investigator could be negatively affected by the study treatment.