metastatic colorectal cancer with an indication for Lonsurf treatment
Conditions
Interventions
Patients treated with Lonsurf will be treated with metformin and cimetidine for 7 and 5 consecutive days respectively.
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Patients with a confirmed diagnosis of metastatic colorectal cancer with an indication for Lonsurf treatment. 3. WHO performance = 1 (see appendix B). 4. Able and willing to sign the Informed Consent Form prior to screening evaluations 5. No concurrent medication or supplements which can interact with either Lonsurf, metformin or cimetidine during the study period (e.g. strong OCT2 or MATE1 inhibitors). (see Appendix C) 6. Abstain from grapefruit, grapefruit juice, herbal dietary supplements, acidic beverages (e.g. Cola) and herbal tea during the study period 7. Adequate baseline patient characteristics (complete blood count, serum biochemistry which involves sodium, potassium, creatinine, calculation of creatinine clearance, AST, ALT, gamma glutamyltranspeptidase, lactate dehydrogenase, ALP, Total bilirubin, Albumin, glucose) 8. BMI 18-30 kg/m2
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients 2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria) 3. Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure (GFR<60), serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases) 4. Patient with any type of diabetes mellitus
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the possible drug interaction between Lonsurf and metformine on metformin plasma trough concentration in patients with metastatic colorectal cancer. 2. Other pharmacokinetic outcomes of both Lonsurf and metformine (i.e. clearance, maximum concentration (Cmax) and time until maximum concentration (tmax)). 3. To evaluate the incidence and severity of side-effects of treatment with Lonsurf in absence and presence of metformin and cimetidine. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the possible drug interaction between Lonsurf and metformin on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer. 2. To determine the possible interaction between Lonsurf and cimetidine on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer. | — |
Contacts
Public ContactKoen Hussaarts
Erasmus MC
Outcome results
None listed