Influence of medicinal cannabis (bedrocan) on the pharmacokinetics of irinotecan and docetaxel in cancer patients

Completed

• Conditions: Cancer

• Registration Number: ISRCTN72088851
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Histological or cytological confirmed diagnosis of any form of (metastatic) cancer:
a. which is refractory to conventional treatment; or
b. for which no other (effective) treatment options are available
2. Age 18 years and older
3. World Health Organisation (WHO) performance grade two or less
4. Adequate hematological functions (absolute neutrophil count more than 2.0 x 10^9/L, platelets more than 100 x 10^9/L)
5. Adequate renal and hepatic functions: bilirubin less than 1.25 x Upper Limit of Normal (ULN); Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) less than 2.5 x ULN, in case of liver metastasis less than 5 x ULN; serum creatinine less than 1.25 x ULN; Alkaline Phosphatase (AP) 5 x ULN; patients with SGPT and/or SGOT more than 1.5 x ULN associated with AP more than 2.5 x ULN 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 three 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

1. Pregnant or lactating patients; patients with reproductive potential must use a reliable method of contraception (excluding oral contraceptives), if required
2. Symptomatic Central Nervous System (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 four weeks, provided that the patient has recovered from all relevant toxic effects
5. Radiotherapy within the last four weeks before chemotherapy, unless less than 20% of the bone marrow area is involved
6. Major surgery within four weeks before study entry (to be determined by a Medical Doctor)
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 four 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified