Effects of Cimetidine on Cisplatin-induced Nephrotoxicity

Completed

Conditions: Head and Neck cancer
10027655

Registration Number: NL-OMON35018

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

•Histological or cytological confirmed diagnosis of any form of irresectable Head and Neck cancer, which is not currently being treated with cisplatin;
•Treatment with high doses of cisplatin (3-weekly 100 mg/m2), with radiotherapy. No other systemic anti-cancer treatment is allowed.
• Age =/>18 years;
• WHO performance =/<1
•Adequate hematological functions (ANC > 1.5 x 109/L, platelets > 100 x 1012/L)
•Adequate renal and hepatic functions (serum creatinin < 1.25xULN, bilirubin < 1.25xULN, ALAT and ASAT < 2.5xULN, in case of liver metastasis < 5 ULN; alkaline phosphatase < 5xULN);
•Written informed consent;
•Complete initial work-up within four weeks prior to therapy with cisplatin or the combination of cisplatin and cimetidine.

Exclusion Criteria

•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 requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
•Current use of cisplatin therapy;
•Patients with Chronic Kidney Disease;
•Major surgery within 4 weeks before start of the protocol (to be evaluated by an MD);
•(Chronic) use of CYP3A and/or ABCB1/ABCG2 inhibiting and inducing medication, dietary supplements, or other inhibiting compounds (see Appendix D);
•Unwillingness to change medication, or no adequate alternatives available, when drugs are taken that are known to interact with CYP3A and/or ABCB1 and/or ABCG2;
•Use of cimetidine 4 weeks prior to study entry.