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

January 10, 2006
March 18, 2013
April 2004
December 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00274768 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Capecitabine in Treating Patients With Metastatic Breast Cancer
Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer

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

  • 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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: capecitabine
Experimental: Capecitabine
Intervention: Drug: capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
November 2012
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00274768
J0425 CDR0000446286, P30CA006973, JHOC-J0425, JHOC-SKCCC-J0425, JHOC-IRB-04032502
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Antonio C. Wolff, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP