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Capecitabine in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00274768
First received: January 10, 2006
Last updated: March 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Participants were followed to progression, evaluated every 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Benefit, Time to Treatment Failure, Safety and Toxicity [ Time Frame: Time to progression ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic and Pharmacodynamic Effects [ Time Frame: Time to progression ] [ Designated as safety issue: No ]
  • Adherence and Compliance to Oral Medication Using Electronic Monitoring [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2004
Study Completion Date: November 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine Drug: capecitabine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274768

Locations
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Antonio C. Wolff, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by Sidney Kimmel Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00274768     History of Changes
Other Study ID Numbers: J0425 CDR0000446286, P30CA006973, JHOC-J0425, JHOC-SKCCC-J0425, JHOC-IRB-04032502
Study First Received: January 10, 2006
Results First Received: November 21, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage IV breast cancer
male breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014