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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00812864
• Date of registration: 19/12/2008
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Limoges
• Public title: Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (= 75 Years) capagec
• Scientific title: Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (=75 Years)
• Date of first enrolment: January 2009
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00812864
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Nicole TUBIANA-MATHIEU, MD
• Affiliation: CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France

Key inclusion & exclusion 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



Age minimum: 75 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Breast Cancer

Colorectal Cancer

Intervention(s)

Drug: Capecitabine

Primary Outcome(s)

Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL. [Time Frame: 1 year]

Secondary Outcome(s)

Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum. [Time Frame: 1 year]

Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6. [Time Frame: 1 year]

Secondary ID(s)

N° EudraCT : 2008-001195-7

I07028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors