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Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years) (capagec)
This study is currently recruiting participants.
Verified by University Hospital, Limoges, September 2009
First Received: December 19, 2008   Last Updated: September 4, 2009   History of Changes
Sponsor: University Hospital, Limoges
Information provided by: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00812864
  Purpose

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


Condition Intervention Phase
Breast Cancer
Colorectal Cancer
Drug: Capecitabine
Phase IV

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years)

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine

    Pharmacokinetic of its metabolites.

    Capecitabine, 1250 mg/m2 twice a day

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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812864

Contacts
Contact: Jean MARTIN, MD 0555056396 oncologie@chu-limoges.fr

Locations
France, Province
CHU Limoges Recruiting
Limoges Cedex, Province, France, 87042
Contact: Jean MARTIN, MD     0555056396     oncologie@chu-limoges.fr    
Contact: Jean MARTIN, MD     0555056396     oncologie@chu-limoges.fr    
Principal Investigator: Jean MARTIN, MD            
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: jean MARTIN, MD CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France
  More Information

No publications provided

Responsible Party: CHU de Limoges ( M.SENGELEN/Directrice de la Recherche clinique et de l'Innovation )
Study ID Numbers: I07028, N° EudraCT : 2008-001195-7
Study First Received: December 19, 2008
Last Updated: September 4, 2009
ClinicalTrials.gov Identifier: NCT00812864     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:
Capecitabine
pharmacocinetics
Breast metastatic cancer
colorectal metastatic cancer
Elderly patients

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Rectal Diseases
Neoplasms by Site
Therapeutic Uses
Breast Diseases
Capecitabine
Digestive System Neoplasms
Skin Diseases
Breast Neoplasms
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010