A Phase 2 interventional study of capecitabine in Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 26 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
Patients must have measurable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
No clinically significant cardiac disease, including the following:
PRIOR CONCURRENT THERAPY:
Up to 3 prior cytotoxic regimens allowed for metastatic disease
No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)
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).
Drug: capecitabine
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).
Also known as: Xeloda
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.
Time frame: Participants were followed to progression, evaluated every 12 weeks
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.
Time frame: 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.
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)
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.
Time frame: 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).
Time frame: 3-week cycles of treatment up to 16 cycles
Time to Treatment Failure
Time to treatment failure in weeks
Time frame: 3-week cycles of treatment up to 16 cycles
Thirty patients with metastatic breast cancer were consented between August 2005 and December 2008. Twenty six patients were eligible and initiated treatment on-study.
| Milestone | Capecitabine |
|---|---|
| Started | 26 |
| Completed | 26 |
| Not completed | 0 |
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.
| participants | Capecitabine |
|---|---|
| Response Rate | 21 |
The overall clinical benefit rate as assessed by number of participants with lack of progression for at least 24 weeks.
| Participants | Capecitabine |
|---|---|
| Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks | 4 |
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.
| ng/mL | Capecitabine |
|---|---|
| Capecitabine | 9324 ± 7015 |
| 5'-DFCR | 6353 ± 2590 |
| 5'-DFUR | 4597 ± 2608 |
| 5-FU | 753 ± 1209 |
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.
| ng*h/mL | Capecitabine |
|---|---|
| Capecitabine | 7255 ± 4180 |
| 5'-DFCR | 11344 ± 5583 |
| 5'-DFUR | 6653 ± 2166 |
| 5-FU | 1230 ± 1826 |
This was assessed by number of participants who did not miss any doses of Capecitabine during treatment using the Medication Event Monitoring System (MEMS).
| Participants | Capecitabine |
|---|---|
| Adherence and Compliance to Oral Medication Using Electronic Monitoring | 13 |
Time to treatment failure in weeks
| weeks | Capecitabine |
|---|---|
| Time to Treatment Failure | 12 (6 to 48) |
Collected over Participants were evaluated for adverse events every cycle, or every 3 weeks; median length of time on trial was 7 cycles (or 21 weeks). Potentially treatment-related toxicities of all grades and for all cycles are listed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capecitabine | 2/26 (7.7%) | 2/26 (7.7%) | 20/26 (76.9%) |
| Event | Capecitabine |
|---|---|
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/26 |
| Event | Capecitabine |
|---|---|
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 20/26 |
| FatigueGeneral disorders | 16/26 |
| NauseaGastrointestinal disorders | 14/26 |
| DiarrheaGastrointestinal disorders | 7/26 |
| VomitingGeneral disorders | 6/26 |
| DyspepsiaGastrointestinal disorders | 6/26 |
| Mucositis oralGastrointestinal disorders | 6/26 |
| AnorexiaMetabolism and nutrition disorders | 5/26 |
| HeadacheNervous system disorders | 5/26 |
| Abdominal painGastrointestinal disorders | 4/26 |
| Age, Categorical(Participants) | Capecitabine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 24 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Capecitabine |
|---|---|
| Female | 26 |
| Male | 0 |
| Region of Enrollment(participants) | Capecitabine |
|---|---|
| United States | 26 |
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins