Breast NeoplasmsPhase 1/2NCT00324610
Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
A Phase 1/2 study testing capecitabine in people with Breast Neoplasms and Chemotherapy, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 1 site in France.
Trial summary
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity. Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Chemotherapy
- What is being tested?
- capecitabine
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to not given
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven breast adenocarcinoma
- Evaluable or measurable metastases
- HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH
- Previously treated with anthracyclines and taxanes
- Age > = 18 y
- No more than two previous chemotherapy regimens for metastases
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- No nervous central system involvement
- Hormonal therapy must have been stopped two weeks before enrollment
- Adequate biologic function
- Performance status OMS < = 2
- Signed informed consent
Who cannot join
- History of other malignancies, except basocellular cancer, in situ cervix carcinoma
- Gastro intestinal disease that might affect absorption of capecitabine
- Cardiac failure or angina pectoris uncontrolled
- Hypersensitivity for capecitabine, fluorouracil, or one of their excipient
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Concomitant anticancer therapy (included hormonotherapy)
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- Concomitant radiotherapy
- Treatment with sorivudine and analogs
- Pregnant or breast feeding patients. Contraception methods excluding hormonal treatment is required.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Ho¨Pital Europeen Georges Pompidou
Paris, 75015
ERIC LEVY, MD, 33-1-56092985, eric.levy@egp.aphp.fr
jacques medioni, MD
About this study
Official title: Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.
Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.
Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen
- Conditions
- Breast Neoplasms, Chemotherapy
- Being tested
- capecitabine
- Keywords
- fluoropyrimidines, metastases, pharmacokinetics, phase 1-2 study
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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 1/2
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
- Sponsor type
- University, hospital or other
- Investigators
- eric levy, MD, Principal investigator, HEGP , PARISjoseph Gligorov, MD, Study chair, HOPITAL TENON, PARISMichèle TUBIANA HULIN, MD, Study chair, CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCEVERONIQUE DIERAS, MD, Study chair, INSTITUT CURIE, PARIS franceRémi LARGILLIER, MD, Study chair, centre antoine lacassagne, NICE, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324610
- Sponsor's protocol ID
- CAP 5/7
- Other IDs
- ARTIC / CAP 5/7
- Status last verified
- May 2006
- First submitted
- 9 May 2006
- Last updated
- 18 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00324610
- Acronym / sponsor ID
- CAP 5/7
- Conditions
- Breast Neoplasms, Chemotherapy
- Keywords
- fluoropyrimidines, metastases, pharmacokinetics, phase 1-2 study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en CancérologieUniversity, hospital or other
- Study start
- Mar 2006
- First posted
- 11 May 2006 (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.
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.
Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.
Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven breast adenocarcinoma
- Evaluable or measurable metastases
- HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH
- Previously treated with anthracyclines and taxanes
- Age > = 18 y
Key exclusion criteria (9 listed)
- History of other malignancies, except basocellular cancer, in situ cervix carcinoma
- Gastro intestinal disease that might affect absorption of capecitabine
- Cardiac failure or angina pectoris uncontrolled
- Hypersensitivity for capecitabine, fluorouracil, or one of their excipient
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
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 |
|---|---|---|
| capecitabine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2006.
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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.
eric levy, MD principal investigator
HEGP , PARIS
joseph Gligorov, MD study chair
HOPITAL TENON, PARIS
Michèle TUBIANA HULIN, MD study chair
CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing capecitabine in people with Breast Neoplasms and Chemotherapy, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie 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 11 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 May 2006. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eric levy, md (33-1-56092985, eric.levy@egp.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 18 May 2006.