Cancer see also inclusion criteria: 1. Histological or cytological confirmed diagnosis of any form of (metastatic) cancer
Conditions
Interventions
Course 1 irinotecan: patients will be treated with 600 mg irinotecan given as a 90-minute intravenous infusion in 250 ml NaCl 0.9% (t=0, day 1, course 1).
Course 1 docetaxel: patients will be treated
Sponsors
Erasmus MC- Daniel den Hoed Kliniek, afdeling Interne Oncologie.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological or cytological confirmed diagnosis of any form of (metastatic) cancer; 1.1 which is refractory to conventional treatment; or 1.2 for which no other (effective) treatment options are available. 2. Age 18 years and older. 3. WHO performance 2 or less (see appendix). 4. Adequate hematological functions (absolute neutrophil count > 2.0x109/L, platelets > 100x109/L). 5. Adequate renal and hepatic functions: bilirubin 1.5xULN associated with AP > 2.5xULN are not eligible for the docetaxel arm. 6. Written informed consent. 7. Complete initial work-up within two weeks prior to chemotherapy. 8. Willingness to abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study period (starting 3 weeks before the first course). 9. Willingness to abstain from alcohol, car-driving, use of dangerous instruments and machinery or engagement in hazardous activity during the time of medicinal cannabis-use because of (non-excludable) interference with logical thinking, ability to concentrate, and response speed.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; patients with reproductive potential must use a reliable method of contraception (excluding oral contraceptives), if required. 2. Symptomatic CNS metastases. 3. Other serious illness or medical unstable condition requiring treatment or history of psychiatric disorder that would prohibit the understanding and giving of informed consent. 4. Time between last anti-tumor chemotherapy treatment and first day of irinotecan or docetaxel therapy less than 4 weeks, provided that the patient has recovered from all relevant toxic effects. 5. Radiotherapy within the last 4 weeks before chemotherapy, unless < 20% of the bone marrow area is involved. 6. Major surgery within 4 weeks before study entry (to be determined by an MD). 7. History of alcohol or drug abuse, including current substance dependence, methadone maintenance. 8. Use of St John’s wort and/or other herbal medicines within 4 weeks before study entry. 9. Current cannabis use and/or history of marijuana/cannabis abuse. 10. (Chronic) use of CYP3A inhibiting medication, dietary supplements or other inhibiting compounds. 11. (Chronic) use of CYP3A inducing medication, dietary supplements or other inducing compounds. 12. Unwillingness to change medication, or no adequate alternatives available, when drugs known to interact with CYP3A isozymes, are taken. 13. History of serious depression, schizophrenia, or psychosis. Additionally for irinotecan patients: 1. Unresolved bowel obstruction or chronic colic disease. 2. Radiotherapy at abdomen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irinotecan and metabolite pharmacokinetics, course 1 and 2 Docetaxel pharmacokinetics, course 1 and 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological toxicity course 1 and 2. | — |
Contacts
Public ContactF.A. Jong, de
Erasmus Medical Center, Daniel den Hoed Kliniek Groene Hilledijk 301
Outcome results
None listed