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Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer



- Determine the response rate in patients with metastatic breast cancer treated with a
fixed-dose of capecitabine.


- 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

- 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.

Inclusion Criteria


- 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


- ECOG (Eastern Cooperative Oncology Group) 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


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Description:

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.

Outcome Time Frame:

Participants were followed to progression, evaluated every 12 weeks

Safety Issue:


Principal Investigator

Antonio C. Wolff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

J0425 CDR0000446286



Start Date:

April 2004

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • male breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



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
DeCesaris Cancer Institute at Anne Arundel Medical Center Annapolis, Maryland  21401