Effects of a short-term dietary restriction regimen in cancer patients receiving irinotecan.
- Conditions
- Cancer10027656
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
*Metastatic colorectal cancer or other solid tumors
*Eligible for treatment with irinotecan 600 mg 3-weekly
*Age * 18 years
*BMI 20-30kg/m2
*WHO performance status 0-1
*Written informed consent
*Adequate renal function, i.e. serum creatinin < 2 x ULN and creatinin clearance > 45 mL/min
*Patients with safely accessible liver metastases and healthy liver tissue
*Adequate coagulation status (PT-INR <1.5, APTT<1.5xULN, on the day of biopsy in patients using coumarines: PT-INR<1.5, Hb>6mmol/L, trombocyten > 100x10 9)
*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.
*Serious illness or medical unstable condition prohibiting adequate treatment and follow-up.
*History of bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
*Patients using any anti-coagulant medication which cannot be safely stopped or counteracted at the time of biopsy
*Unable or unwilling to stop the use of (over the counter) medication of (herbal) supplements which can interact with irinotecan (e.g. by induction or inhibition of CYP3A4 (see Appendix B))
*Unable or unwilling to abstain from grapefruit or grapefruit juice during the study
*Bilirubin > 1.5 x ULN, ASAT > 5x ULN, ALAT >5x ULN
*Uncontrolled hypertension, despite medical treatment
*Cows milk and/or soy allergy and/or lactose intolerance
*Patients using insulin
*Patients with hyperventilation
*Patients unable of unwilling to fill in a food diary
*Patients using oxygen and not able to stop for 30 minutes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate a 25% reduction of the active irinotecan metabolite, SN38, in<br /><br>healthy liver tissue (without reducing the intra-tumoral SN38 concentration),<br /><br>24-26 hours after irinotecan administration with preceding dietary restriction<br /><br>compared to without preceding dietary restriction. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To determine intra-tumoral irinotecan and SN-38 concentrations with and<br /><br>without preceding dietary restriction.<br /><br>- To determine the systemic PK parameters of irinotecan in peripheral blood<br /><br>with and without preceding dietary restriction.<br /><br>- To determine leukocyte number with and without preceding dietary restriction<br /><br>- Toxicity of irinotecan with and without preceding dietary restriction.<br /><br>- Transcriptome analysis of tumor and liver to identify mechanisms responsible<br /><br>for increased intra-tumoral irinotecan concentrations and decreased side<br /><br>effects.</p><br>