Breast CancerPhase 4capagecNCT00812864
Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years)
A Phase 4 study testing Capecitabine in people with Breast Cancer and Colorectal Cancer, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer, Colorectal Cancer
- Being tested
- Capecitabine
- Keywords
- Capecitabine, pharmacocinetics, Breast metastatic cancer, colorectal metastatic cancer, Elderly patients
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Pharmacokinetic of its metabolites.
Capecitabine, 1250 mg/m2 twice a day
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Not described Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL.
pharmacokinetics of capécitabine
Measured: 1 year
Secondary outcomes (2)
Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum.
Adverse effects
Measured: 1 year
Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole TUBIANA-MATHIEU, MD, Principal investigator, CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812864
- Sponsor's protocol ID
- I07028
- Other IDs
- N° EudraCT : 2008-001195-7
- Acronym
- capagec
- Status last verified
- Sep 2009
- First submitted
- 19 Dec 2008
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24801171
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years)
- ClinicalTrials.gov ID
- NCT00812864
- Acronym / sponsor ID
- capagec / I07028
- Conditions
- Breast Cancer, Colorectal Cancer
- Keywords
- Capecitabine, pharmacocinetics, Breast metastatic cancer, colorectal metastatic cancer, Elderly patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: Capecitabine |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabinePharmacokinetic of its metabolites. Capecitabine, 1250 mg/m2 twice a day | Drug | Capecitabine |
Primary outcome
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
2 secondary outcomes
Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum.
Time frame: 1 year
Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Results publication: PubMed 24801171Daher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole TUBIANA-MATHIEU, MD principal investigator
CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Capecitabine in people with Breast Cancer and Colorectal Cancer, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00812864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.