Breast CancerPhase 2NCT00274768
Capecitabine in Treating Patients With Metastatic Breast Cancer
A Phase 2 study testing capecitabine in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
- Evidence of metastatic involvement (stage IV disease)
- Patients must have measurable disease
- At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
- Treated brain metastases (surgery or radiation therapy) allowed if clinically stable
- Patients with leptomeningeal disease are ineligible
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Male or female
- Menopausal status not specified
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine clearance > 50 mL/min
- Fertile patients must use effective contraception
- No history of another severe and/or life-threatening medical disease
- No other active primary malignancy
- Not pregnant or nursing
- Negative pregnancy test
- Patients with asymptomatic HIV infection are eligible
- Liver dysfunction score ≤ 9
- No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)
- No active gastrointestinal malabsorption illness
- No clinically significant cardiac disease, including the following:
- Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months
- No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency
- No history of uncontrolled seizures or central nervous system disorders
- No significant history of noncompliance to medical regimens
- No clinically significant psychiatric disability that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- No previous capecitabine
- Up to 3 prior cytotoxic regimens allowed for metastatic disease
- Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)
- No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy
- No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy
- No other concurrent investigational drugs
- No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)
- Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
- At least 4 weeks since prior sorivudine or brivudine
- Concurrent use of bisphosphonates allowed if initiated before beginning study therapy
- Concurrent use of megestrol acetate suspension as an appetite stimulant allowed
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.
Secondary
- Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
- Correlate pharmacodynamic effects of this drug with toxicity and response in these patients.
- Determine compliance and adherence to this regimen and correlate with PK parameters in these patients.
OUTLINE: This is an open-label study.
Patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- capecitabine
- Keywords
- stage IV breast cancer, male breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called Xeloda
A total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16).
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | 26 patients received the pre-defined starting dose of capecitabine of 3,000 mg orally daily given in two divided doses. Two thirds of the patients received either the same dose or a 500 mg lower dose compared to what would have been administered with a commonly used body surface area (BSA)-dosing schedule (2,000 mg/m2 with rounding down to nearest 500 mg multiple). Receives: Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Participants were followed to progression, evaluated every 12 weeks
Secondary outcomes (5)
Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks
The overall clinical benefit rate as assessed by number of participants with lack of progression for at least 24 weeks.
Measured: 3-week cycles of treatment up to 16 cycles
Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration
Pharmacokinetics of Capecitabine and metabolites [5-fluoro-5'-deoxycytidine (5'-DFCR), 5-fluoro-5'-dexoxyuridine (5'-DFUR), and 5-fluorouracil (FU)] assessed using maximum plasma concentration (Cmax) in ng/mL.
Measured: 0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours
Pharmacokinetics of Capecitabine and Metabolites as Assessed by Area Under the Curve (AUC)
Pharmacokinetics of Capecitabine and metabolites [5-fluoro-5'-deoxycytidine (5'-DFCR), 5-fluoro-5'-dexoxyuridine (5'-DFUR), and 5-FU] assessed using AUC in ng*h/mL.
Measured: 0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours
Adherence and Compliance to Oral Medication Using Electronic Monitoring
This was assessed by number of participants who did not miss any doses of Capecitabine during treatment using the Medication Event Monitoring System (MEMS).
Measured: 3-week cycles of treatment up to 16 cycles
Time to Treatment Failure
Time to treatment failure in weeks
Measured: 3-week cycles of treatment up to 16 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startApr 2004
- Primary completionDec 2009
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Antonio C. Wolff, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274768
- Sponsor's protocol ID
- J0425 CDR0000446286
- Other IDs
- P30CA006973, JHOC-J0425, JHOC-SKCCC-J0425, JHOC-IRB-04032502
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2006
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fackler MJ, Lopez Bujanda Z, Umbricht C, Teo WW, Cho S, Zhang Z, Visvanathan K, Jeter S, Argani P, Wang C, Lyman JP, de Brot M, Ingle JN, Boughey J, McGuire K, King TA, Carey LA, Cope L, Wolff AC, Sukumar S. Novel methylated biomarkers and a robust assay to detect circulating tumor DNA in metastatic breast cancer. Cancer Res. 2014 Apr 15;74(8):2160-70. doi: 10.1158/0008-5472.CAN-13-3392.
PubMed 24737128
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00274768
- Acronym / sponsor ID
- J0425 CDR0000446286
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, male breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Posted 21 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.
Secondary
- Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
- Correlate pharmacodynamic effects of this drug with toxicity and response in these patients.
- Determine compliance and adherence to this regimen and correlate with PK parameters in these patients.
OUTLINE: This is an open-label study.
Patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
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: capecitabine26 patients received the pre-defined starting dose of capecitabine of 3,000 mg orally daily given in two divided doses. Two thirds of the patients received either the same dose or a 500 mg lower dose compared to what would have been administered with a commonly used body surface area (BSA)-dosing schedule (2,000 mg/m2 with rounding down to nearest 500 mg multiple). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: XelodaA total of 115 cycles of therapy were administered and five patients did not complete cycle 1. The median number of cycles initiated was four (range 1-16). | Drug | Capecitabine |
Primary outcome
Response Rate
Time frame: Participants were followed to progression, evaluated every 12 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
5 secondary outcomes
Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks
Time frame: 3-week cycles of treatment up to 16 cycles
Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration
Time frame: 0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours
Pharmacokinetics of Capecitabine and Metabolites as Assessed by Area Under the Curve (AUC)
Time frame: 0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours
Adherence and Compliance to Oral Medication Using Electronic Monitoring
Time frame: 3-week cycles of treatment up to 16 cycles
Time to Treatment Failure
Time frame: 3-week cycles of treatment up to 16 cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24737128Fackler MJ, Lopez Bujanda Z, Umbricht C, Teo WW, Cho S, Zhang Z, Visvanathan K, Jeter S, Argani P, Wang C, Lyman JP, de Brot M, Ingle JN, Boughey J, McGuire K, King TA, Carey LA, Cope L, Wolff AC, Sukumar S. Novel methylated biomarkers and a robust assay to detect circulating tumor DNA in metastatic breast cancer. Cancer Res. 2014 Apr 15;74(8):2160-70. doi: 10.1158/0008-5472.CAN-13-3392.
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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.
Antonio C. Wolff, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 21 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (time frame: Participants were followed to progression, evaluated every 12 weeks). 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 NCT00274768, 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 27 Jan 2020.