Breast CancerPhase 2NCT00960544
Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism
A Phase 2 study testing Capecitabine in people with Breast Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jan 2021
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the breast.
- Patients must give informed consent for protocol participation.
- Age >/= 18 years
- Patients must have and ECOG performance status of </=2.
- Patients must be scheduled to receive capecitabine using a BID dosing strategy administered on days 1-14 of a 21-day cycle.
- Patients must agree to blood draws for PK/PD sampling.
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- Patients are allowed to receive cytotoxic therapy in combination with capecitabine.
- Patients must not require concurrent radiation, or hormonal therapy while receiving protocol therapy
- Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics as prophylaxis is allowed.
- Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. Both men and women should practice an effective method of birth control while receiving capecitabine.
- Patients must have recovered to grade <1 from all acute toxicity of previous chemotherapy, radiation or hormonal therapy and have adequate hematologic and hepatic function: Granulocyte count >/= 1,500/mcL; Platelet count >/= 100,000/mcL; Bilirubin </= 1.5 x ULN; AST and/or ALT </= 2 x ULN; Alkaline phosphatase (liver component, if fractionated) </= 2 x ULN; Serum creatinine within normal limits.
Who cannot join
- Untreated or uncontrolled brain metastasis
- History of prior therapy with capecitabine
- Patient inability to take or absorb oral medications
About this study
Official title: Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan
The goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied.
Read the detailed description
Capecitabine, PK Testing, and DNA Analysis:
Capecitabine is designed to interfere with the growth of cancer cells, which may cause the cells to die. It is cleared from the body by certain proteins (which are made from DNA--the gene material of cells). Some patients have changes in these proteins that increase or decrease the rate that capecitabine is cleared from the body.
Researchers will use pharmacokinetic (PK) testing and DNA analysis to learn how capecitabine is cleared from your body. PK testing measures the amount of drug in the body at different time points. Information learned in this study may help researchers decide the best doses of capecitabine for future patients with breast cancer.
Screening Visit:
Before you can start treatment on this study, you will have about 2 teaspoons of blood drawn for routine tests and to make sure that you are able to receive chemotherapy. This screening blood test will help the study doctor decide if you are eligible to take part in this study.
Capecitabine Treatment:
If you are found to be eligible to take part in this study, you will be given capecitabine by mouth on the day you choose to start this therapy. Your treating doctor will prescribe capecitabine at a dose that is appropriate to treat the cancer. You can choose the start date, excluding weekends, but will need to begin therapy in the morning of the day you choose. You will have treatment with capecitabine even if you do not participate on this study.
PK Testing and DNA Analysis:
You will have blood drawn (about 2 teaspoons each time) for PK testing and DNA analysis of capecitabine at certain times throughout this study.
- For PK testing, blood will be drawn before your first dose of capecitabine, at 30, 60, and 90 minutes after the first dose, and then at 2, 6, 8, and 10 hours after the first dose.
- For DNA analysis, blood will only be drawn before you receive the first dose of capecitabine.
If your dose changes, these PK blood tests may need to be repeated.
Length of Study:
You will remain on this study for up to 6 months, unless the disease gets worse, you experience any intolerable side effects, or you decide to stop treatment with capecitabine.
This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Capecitabine
- Keywords
- Capecitabine, Xeloda, Gene expression, Pharmacokinetic testing, PK sampling, DNA analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Capecitabine - Routine administration of twice daily dosing for days 1-14 of a 21-day cycle. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
Measured: PK testing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJan 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Principal Investigator departed from institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Myriad Genetic Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Phuong Khanh Morrow, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960544
- Sponsor's protocol ID
- 2007-0003
- Status last verified
- Jun 2019
- First submitted
- 17 Aug 2009
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan
- ClinicalTrials.gov ID
- NCT00960544
- Acronym / sponsor ID
- 2007-0003
- Conditions
- Breast Cancer
- Keywords
- Capecitabine, Xeloda, Gene expression, Pharmacokinetic testing, PK sampling, DNA analysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator departed from institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Myriad Genetic Laboratories, Inc.
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 18 Aug 2009 (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 goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied.
Detailed description
Capecitabine, PK Testing, and DNA Analysis:
Capecitabine is designed to interfere with the growth of cancer cells, which may cause the cells to die. It is cleared from the body by certain proteins (which are made from DNA--the gene material of cells). Some patients have changes in these proteins that increase or decrease the rate that capecitabine is cleared from the body.
Researchers will use pharmacokinetic (PK) testing and DNA analysis to learn how capecitabine is cleared from your body. PK testing measures the amount of drug in the body at different time points. Information learned in this study may help researchers decide the best doses of capecitabine for future patients with breast cancer.
Screening Visit:
Before you can start treatment on this study, you will have about 2 teaspoons of blood drawn for routine tests and to make sure that you are able to receive chemotherapy. This screening blood test will help the study doctor decide if you are eligible to take part in this study.
Capecitabine Treatment:
If you are found to be eligible to take part in this study, you will be given capecitabine by mouth on the day you choose to start this therapy. Your treating doctor will prescribe capecitabine at a dose that is appropriate to treat the cancer. You can choose the start date, excluding weekends, but will need to begin therapy in the morning of the day you choose. You will have treatment with capecitabine even if you do not participate on this study.
PK Testing and DNA Analysis:
You will have blood drawn (about 2 teaspoons each time) for PK testing and DNA analysis of capecitabine at certain times throughout this study.
- For PK testing, blood will be drawn before your first dose of capecitabine, at 30, 60, and 90 minutes after the first dose, and then at 2, 6, 8, and 10 hours after the first dose.
- For DNA analysis, blood will only be drawn before you receive the first dose of capecitabine.
If your dose changes, these PK blood tests may need to be repeated.
Length of Study:
You will remain on this study for up to 6 months, unless the disease gets worse, you experience any intolerable side effects, or you decide to stop treatment with capecitabine.
This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabineCapecitabine - Routine administration of twice daily dosing for days 1-14 of a 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the breast.
- Patients must give informed consent for protocol participation.
- Age >/= 18 years
- Patients must have and ECOG performance status of </=2.
- Patients must be scheduled to receive capecitabine using a BID dosing strategy administered on days 1-14 of a 21-day cycle.
Key exclusion criteria (3 listed)
- Untreated or uncontrolled brain metastasis
- History of prior therapy with capecitabine
- Patient inability to take or absorb oral medications
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 |
|---|---|---|
| CapecitabineAlso: XelodaRoutine administration of twice daily dosing for days 1-14 of a 21-day cycle. | Drug | Capecitabine |
Primary outcome
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
Time frame: PK testing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose.
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Phuong Khanh Morrow, MD study chair
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Breast Cancer, run by M.D. Anderson Cancer Center.
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 3 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: withdrawn, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling) (time frame: PK testing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose.). It is what the study was designed to measure, not a finding.
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 14 Jun 2019.