COCA study
Recruiting
- Conditions
- Colorectal carcinoma
- Registration Number
- NL-OMON27946
- Lead Sponsor
- ErasmusMC Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 22
Inclusion Criteria
Age ≥ 18 years.
- Histologically or cytologically confirmed diagnosis of colorectal carcinoma for which capecitabine is an appropriate treatment option.
Exclusion Criteria
- Prior treatment with capecitabine is allowed, however, patients with a documented history of ≥ grade 3 toxicities with capecitabine are excluded.
- Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A relative difference in the AUC of at least 25% is considered to be clinically relevant (i.e. ratio of geometric means ≤0.75 or ≥1.33) and the within-patient standard deviation is assumed to be 27%
- Secondary Outcome Measures
Name Time Method - to study other PK parameters, including the clearance (CL), the maximum concentration (Cmax), and time of Cmax (tmax) of capecitabine. <br /><br>- 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. <br /><br>- 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.<br>