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

Phase 4
75 Years
Not Enrolling
Breast Cancer, Colorectal Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2009

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Capecitabine
  • pharmacocinetics
  • Breast metastatic cancer
  • colorectal metastatic cancer
  • Elderly patients
  • Breast Neoplasms
  • Colorectal Neoplasms