Colorectal carcinoma or other solid tumours
Conditions
Interventions
Trade Name: capecitabine
Pharmaceutical Form: Film-coated tablet
Trade Name: Nexium
Pharmaceutical Form: Gastro-resistant tablet
Sponsors
Erasmus MC Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Histologically or cytologically confirmed diagnosis of a solid tumour for which capecitabine is an appropriate treatment option. 3. Planned treatment with capecitabine. 4. ECOG Performance Status =2 5. Able and willing to sign the informed consent form prior to screening evaluations. 6. No concurrent (over the counter) use of other acid reducing drugs (PPIs, H2As and/or antacids) other than esomeprazole 40 mg once daily during the study. 7. Abstain from acid beverage (on study days, except for the Coca-Cola in Phase C according to study procedures), grapefruit, grapefruit juice, grapefruit-related citrus fruits, herbal dietary supplements and herbal tea during the study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 1. Prior treatment with capecitabine is allowed, however, patients with a documented history of = grade 3 toxicities with capecitabine are excluded. 2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria) 3. Known serious illness or medical unstable conditions (e.g. instable diabetes mellitus) that could interfere with the study medication/liquid. 4. Patients who are clinical dependent of use of PPIs or other acid reducing drugs. 5. Known complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity. 6. Known poor metabolizers of cytochrome P450 2C19. 7. Use of cytochrome P450 2C19/ 3A4 inducers and or inhibitors. 8. Use of medicines/supplements wich can interact by capecitabine or esomeprazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the area under the plasma concentration-time curve (AUC) of capecitabine alone, compared to capecitabine used with esomeprazole and compared with capacitabine used with esomeprazole and the acid beverage Coca-Cola Classic in patients with CRC or other solid tumours. ;Secondary Objective: 1. to study other PK parameters, including the clearance (CL), the maximum concentration (Cmax), and time of Cmax (tmax) of capecitabine. 2. to determine AUC, CL, Cmax and tmax of the metabolites of capecitabine: 5'-deoxy-5-fluorocytidine (5’-DFCR), 5'-deoxy-5-fluorouridine (5’-DFUR) and 5-FU. 3. to evaluate the incidence and severity of side- effects of treatment with capecitabine in the presence of esomeprazole alone and in the presence of esomeprazole combined with the acid beverage Coca-Cola Classic. ;Primary end point(s): To evaluate the area under the plasma concentration-time curve (AUC) of capecitabine alone, compared to capecitabine used with esomeprazole and compared with capacitabine used with esomeprazole and the acid beverage Coca-Cola Classic in patients with CRC or other solid tumours. ;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. to study other PK parameters, including the clearance (CL), the maximum concentration (Cmax), and time of Cmax (tmax) of capecitabine. 2. to determine AUC, CL, Cmax and tmax of the metabolites of capecitabine: 5'-deoxy-5-fluorocytidine (5’-DFCR), 5'-deoxy-5-fluorouridine (5’-DFUR) and 5-FU. 3. to evaluate the incidence and severity of side- effects of treatment with capecitabine in the presence of esomeprazole alone and in the presence of esomeprazole combined with the acid beverage Coca-Cola Classic. ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Contacts
Public ContactA.H.J. Mathijssen
Erasmus MC Cancer Institute
Outcome results
None listed