Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma
- Conditions
- Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma (G3) with a Ki67 of 20-55%MedDRA version: 21.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002524-16-DK
- Lead Sponsor
- Dept of Oncology. Haukeland University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
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
•Prior chemotherapy for advanced/metastatic disease.
•Adjuvant chemotherapy must have ended > 6 months before inclusion.
•Pregnancy or breast-feeding. Fertile patients must use adequate contraception.
•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 Main Objective: •To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.;Secondary Objective: To assess:<br><br>•Overall survival <br>•Progression free survival<br>•Objective response rate<br>•Response duration<br>•Safety profile<br>•Quality of life using EORTC QLQ-C30 <br>;Primary end point(s): Disease control rate (CR+PR+SD) at six months according to RECIST-criteria (version 1.1). ;Timepoint(s) of evaluation of this end point: Baseline CT scans must be taken within 15 days prior to start of treatment.<br>First CT evaluation must be performed after 6 weeks on treatment.<br>Thereafter patients should be evaluated every 8th (+/- 2) week.<br>
- Secondary Outcome Measures
Name Time Method