Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

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
•Measurable disease according to RECIST criteria v 1.1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

•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.
•Patients with history of another primary malignancy within the last 3 years, with the exception of locally treated non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
•Patients that can be expected to not be able to comply to study treatment.
•Patients using significant inducers or inhibitors of CYP3A4 or P-glycoprotein (PgP) substrates 2 weeks prior to start of study medications

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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