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Trial record 93 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00812864
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : August 28, 2018
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Drug: Capecitabine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years)
Study Start Date : January 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Capecitabine Drug: Capecitabine

Pharmacokinetic of its metabolites.

Capecitabine, 1250 mg/m2 twice a day

Primary Outcome Measures :
  1. 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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812864

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CHU Limoges
Limoges Cedex, Province, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
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Principal Investigator: Nicole TUBIANA-MATHIEU, MD CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France

Publications of Results:
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Responsible Party: University Hospital, Limoges Identifier: NCT00812864     History of Changes
Other Study ID Numbers: I07028
N° EudraCT : 2008-001195-7
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: September 2009
Keywords provided by University Hospital, Limoges:
Breast metastatic cancer
colorectal metastatic cancer
Elderly patients
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents