Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years) (NCT00812864) | Clinical Trial Compass
CompletedPhase 4
Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years)
France20 participantsStarted 2009-01
Plain-language summary
The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.
Who can participate
Age range75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …