Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years) - Full Text View

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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by University Hospital, Limoges. Recruitment status was Recruiting

First Received on December 19, 2008. Last Updated on September 4, 2009 History of Changes

Sponsor:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00812864

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 IV

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

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 ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: Jean MARTIN, MD

0555056396

oncologie@chu-limoges.fr

Locations

France
CHU Limoges	Recruiting
Limoges Cedex, Province, France, 87042
Contact: Jean MARTIN, MD 0555056396 oncologie@chu-limoges.fr
Principal Investigator: Jean MARTIN, MD

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:

jean MARTIN, MD

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

More Information

No publications provided

Responsible Party:	M.SENGELEN/Directrice de la Recherche clinique et de l'Innovation, CHU de 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:	September 4, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

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 February 09, 2012