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

August 24, 2018 updated by: University Hospital, Limoges

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Province
      • Limoges Cedex, Province, France, 87042
        • CHU Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capecitabine
Drug: Capecitabine

Pharmacokinetic of its metabolites.

Capecitabine, 1250 mg/m2 twice a day

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I07028
  • N° EudraCT : 2008-001195-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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