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

University of Limoges (UL)

Status and phase

Completed

Phase 4

Conditions

Breast Cancer

Colorectal Cancer

Treatments

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

I07028

N° EudraCT : 2008-001195-7

Details and patient eligibility

About

The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.

Full description

Blood samples will be taken before 1rst course of chemotherapy of capécitabine for colorectal or breast metastatic cancer.

Pharmacokinetic will be realizes at several times (H0,5, H1, H1,5, H2, H4, H6, H8) and repeated at D14 of the 2d cycle

Enrollment

20 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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