Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years) (capagec)

Inclusion Criteria:

• Elderly patients 75 years old or more
• Life expectancy of greater then or equal to 6 months
• Histologically proven metastatic breast or colorectal cancer, requiring a chemotherapy by capecitabine according to the habitual schema
• Metastatic situation whatever treatment line
• Previous hormonotherapy for breast cancer, prior chemotherapy (without capecitabine) in adjuvant and/or metastatic indication (colorectal or breast cancer), or radiotherapy (colorectal or breast cancer) are allowed
• One or more measurable target lesion (RECIST criteria)
• ADL>4 (geriatric scales)
• GSD<12 (geriatric scales)
• Laboratory values :
• creatinine clearance (CrCl) >=30 mL/min according to Cockcroft formula
• Adequate bone marrow function (neutrophils count > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin [Hb] > 10g/dl)
• Adequate hepatic function: total bilirubin < 1,5 x upper normal limit, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 2,5x upper normal limits (in case of liver metastases < 5 x upper normal limits)
• Alcalin phosphatases <=2,5x ULN (<=5 x ULN if liver metastases present).
• Subjects must be willing to be followed during the course of treatment/observation and follow-up.
• Signed written informed consent before first course of chemotheray

Exclusion Criteria:

• Age < 75 years
• known brain metastases
• Concomitant oncologic treatment ongoing
• History of severe or unscheduled reaction to fluoropyrimidine treatment
• Prior unanticipated severe reaction to capecitabine or metabolites and to fluoropyrimidine therapy
• Patient with leucopenia
• sorivudine or chemical analogues treatment like brivudine
• Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
• Concomitant severe affections wich lead life expectancy inferior to 3 monthes
• Uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure, coronarian spasmes
• No possible oral administration
• known DPD deficiency
• Treatment with experimental therapy ongoing or within four weeks before inclusion.
• Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the uterin cervix or basal or squamous cell carcinoma of the skin