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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00812864
First received: December 19, 2008
Last updated: December 4, 2012
Last verified: September 2009
  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 4

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

Enrollment: 20
Study Start Date: January 2009
Study Completion Date: November 2012
Primary Completion Date: October 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812864

Locations
France
CHU Limoges
Limoges Cedex, Province, France, 87042
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00812864     History of Changes
Other Study ID Numbers: I07028, N° EudraCT : 2008-001195-7
Study First Received: December 19, 2008
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 19, 2014