None listed
Conditions
Interventions
In a counterbalanced design half of the patients will receive concomitant administration of cimetidine with their cisplatin on the initial day of treatment and no cimetidine on the second day of treat
Sponsors
Erasmus MC Rotterdam-Daniel den Hoed Cancer Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological or cytological confirmed diagnosis of any form of irresectable and/or metastatic Head and Neck cancer, which is not currently being treated with cisplatin; 2. Treatment with high doses of cisplatin (3-weekly 100 mg/m2), with radiotherapy. No other systemic anti-cancer treatment is allowed; 3. Age > 18 years; 4. WHO performance 1.5 x 109/L, platelets > 100 x 1012/L); 6. 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); 7. Written informed consent; 8. Complete initial work-up within four weeks prior to therapy with cisplatin or the combination of cisplatin and cimetidine.
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. 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; 3. Current use of cisplatin therapy; 4. Patients with Chronic Kidney Disease; 5. Major surgery within 4 weeks before start of the protocol (to be evaluated by an MD); 6. (Chronic) use of CYP3A and/or ABCB1/ABCG2 inhibiting and inducing medication, dietary supplements, or other inhibiting compounds (see Appendix D); 7. 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; 8. Use of cimetidine 4 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the ability of cimetidine to prevent cisplatin-induced nephrotoxicity, while not impairing the efficacy of cisplatin in Head and Neck cancer patients. Urine and blood work will be done to establish baseline kidney function/damage. | — |
Contacts
Public ContactL. Gerven, van
Groene Hilledijk 301, Room G4-79
Outcome results
None listed