Capecitabine in Treating Patients With Metastatic Breast Cancer

NCT ID: NCT00274768

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2012-11-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine

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).

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Xeloda

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio C. Wolff, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24737128 (View on PubMed)

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J0425

Identifier Type: OTHER

Identifier Source: secondary_id

JHOC-SKCCC-J0425

Identifier Type: OTHER

Identifier Source: secondary_id

JHOC-IRB-04032502

Identifier Type: OTHER

Identifier Source: secondary_id

J0425 CDR0000446286

Identifier Type: -

Identifier Source: org_study_id