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

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

Detailed Description
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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

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

Conditions
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Breast Cancer, Colorectal Cancer

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br> | Drug: Capecitabine<br>* Pharmacokinetic of its metabolites. Capecitabine, 1250 mg/m2 twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL. | pharmacokinetics of capécitabine | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum. | Adverse effects | 1 year | 
| Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capecitabine, pharmacocinetics, Breast metastatic cancer, colorectal metastatic cancer, Elderly patients