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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

December 19, 2008
December 4, 2012
January 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00812864 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum.
  • Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6.
  • Quality of life.
Not Provided
Not Provided
 
Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years)
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.

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer
  • Colorectal Cancer
Drug: Capecitabine

Pharmacokinetic of its metabolites.

Capecitabine, 1250 mg/m2 twice a day

Not Provided
Daher Abdi Z, Lavau-Denes S, Prémaud A, Urien S, Sauvage FL, Martin J, Leobon S, Marquet P, Tubiana-Mathieu N, Rousseau A. Pharmacokinetics and exposure-effect relationships of capecitabine in elderly patients with breast or colorectal cancer. Cancer Chemother Pharmacol. 2014 Jun;73(6):1285-93. doi: 10.1007/s00280-014-2466-0. Epub 2014 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
75 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00812864
I07028, N° EudraCT : 2008-001195-7
No
University Hospital, Limoges
University Hospital, Limoges
Not Provided
Principal Investigator: Nicole TUBIANA-MATHIEU, MD CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France
University Hospital, Limoges
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP