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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Treatments: Capecitabine

Criteria

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