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

Primary Purpose

Breast Cancer, Colorectal Cancer

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Capecitabine

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Capecitabine, pharmacocinetics, Breast metastatic cancer, colorectal metastatic cancer, Elderly patients

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Limoges

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine

Arm Description

Outcomes

Primary Outcome Measures

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

pharmacokinetics of capécitabine

Secondary Outcome Measures

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

Adverse effects

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

Full Information

NCT ID

NCT00812864

First Posted

December 19, 2008

Last Updated

August 24, 2018

Sponsor

University Hospital, Limoges

1. Study Identification

Unique Protocol Identification Number

NCT00812864

Brief Title

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

Acronym

capagec

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Limoges

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

pharmacokinetics of capécitabine

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Description

Adverse effects

Time Frame

1 year

Title

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicole TUBIANA-MATHIEU, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Limoges

City

Limoges Cedex

State/Province

Province

ZIP/Postal Code

87042

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

24801171

Citation

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.

Results Reference

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

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