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

NCT00812864 | Completed Phase 4

• 2 other identifiers: I07028N° EudraCT : 2008-001195-7
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer

Keywords

Capecitabine; pharmacocinetics; Breast metastatic cancer; colorectal metastatic cancer; Elderly patients

Outcome Measures

Primary Outcomes (1)

• Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL.

  pharmacokinetics of capécitabine

  1 year

Secondary Outcomes (2)

• Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum.

  1 year

• Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6.

  1 year

Study Arms (1)

Capecitabine

EXPERIMENTAL

Drug: Capecitabine

Interventions

Capecitabine DRUG

Pharmacokinetic of its metabolites. Capecitabine, 1250 mg/m2 twice a day

Capecitabine

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

CHU Limoges

Limoges, Province, 87042, France

Location

Related Publications (1)

• Daher Abdi Z, Lavau-Denes S, Premaud 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.

  PMID: 24801171 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Nicole TUBIANA-MATHIEU, MD

  CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2012
• Last Updated: August 28, 2018

Record last verified: 2009-09

Locations

FR (1)