Dietary restriction followed by irinotecan chemotherapy
Completed
- Conditions
- Dietary restriction FastingMetastatic colorectal carcinoma IrinotecanDieetrestrictieVastenGemetastaseerd colorectaal carcinoomIrinotecan
- Registration Number
- NL-OMON29351
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
•Metastatic colorectal cancer and other solid tumors
•Treatment with irinotecan 600 mg 3-weekly
Exclusion Criteria
•Previous treatment with irinotecan within the last 6 months
•Pregnant or lactating patients; patients with reproductive potential must use a reliable method of contraception (excluding oral contraceptives), if required.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective is to demonstrate a 25% reduction of the active irinotecan metabolite, SN38, in healthy liver tissue (without reducing the intra-tumoral SN38 concentration) in patients with mCRC and other solid tumors as a result of preceding dietary restriction.
- Secondary Outcome Measures
Name Time Method Secondary objectives are systemic and intratumoral irinotecan pharmacokinetics and toxicity.