Capecitabine in Treating Patients With Metastatic Breast Cancer

NCT00274768 | Completed Phase 2 Results

• 5 other identifiers: J0425 CDR0000446286P30CA006973JHOC-J0425JHOC-SKCCC-J0425JHOC-IRB-04032502
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; male breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  3-week cycles of treatment up to 16 cycles

• Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration

  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)

  0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours

• Adherence and Compliance to Oral Medication Using Electronic Monitoring

  3-week cycles of treatment up to 16 cycles

• Time to Treatment Failure

  3-week cycles of treatment up to 16 cycles

Study Arms (1)

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).

Drug: capecitabine

Interventions

capecitabine 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).

Also known as: Xeloda

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 24737128 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

The small sample size limited a number of the secondary objectives.

Results Point of Contact

• Title: Dr. Antonio Wolff
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

awolff@jhmi.edu

410-614-6192

Study Officials

• Antonio C. Wolff, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: April 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: November 1, 2012
• Last Updated: January 27, 2020
• Results First Posted: December 21, 2012

Record last verified: 2020-01

Locations

US (3)