The effects of the proton pump inhibitor esomeprazole alone or in combination with Coca-Cola on the absorption of Capecitabine in patients with colorectal cancer or other solid tumours. the COCA study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

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 (see Appendix B).
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.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
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 which can interact by capecitabine or esomeprazole

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To evaluate the area under the plasma concentration-time curve (AUC) of<br /><br>capecitabine alone, compared to capecitabine used with esomeprazole and<br /><br>compared with capacitabine used with esomeprazole and the acid beverage<br /><br>Coca-Cola Classic in patients with CRC or other solid tumours.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. to study other PK parameters, including the clearance (CL), the maximum<br /><br>concentration (Cmax), and time of Cmax (tmax) of capecitabine.<br /><br>2. to determine AUC, CL, Cmax and tmax of the metabolites of capecitabine:<br /><br>5'-deoxy-5-fluorocytidine (5-DFCR), 5'-deoxy-5-fluorouridine (5-DFUR) and<br /><br>5-FU.<br /><br>3. to evaluate the incidence and severity of side- effects of treatment with<br /><br>capecitabine in the presence of esomeprazole alone and in the presence of<br /><br>esomeprazole combined with the acid beverage Coca-Cola Classic.</p><br>