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Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00146588
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : March 24, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

September 6, 2005
September 7, 2005
March 24, 2015
April 2002
December 2004   (Final data collection date for primary outcome measure)
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer. [ Time Frame: 2 years ]
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.
Complete list of historical versions of study NCT00146588 on ClinicalTrials.gov Archive Site
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Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer
A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.
  • Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment.
  • Patients will receive cytoxan (cyclophosphamide) and epirubicin intravenously on day 1 of each treatment cycle. On days 4-17 of each cycle, patients will take capecitabine orally twice a day.
  • While on the study patients will be required to complete a diary of they capecitabine treatment.
  • Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patient's experience with the oral chemotherapy.
  • Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects.
Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Drug: Cyclophosphamide
    Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
    Other Name: Cytoxan
  • Drug: Epirubicin
    Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
  • Drug: Capecitabine
    Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
December 2004
December 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
  • 18 years of age or older
  • ANC > 1,000/mm3
  • Platelet count > 100,000/mm3
  • Hemoglobin > 10
  • Creatinine < 2.0
  • SGOT < 2 x ULN
  • Bilirubin < 1.5mg/dl
  • Able to swallow and retain oral medication
  • LVEF greater than or equal to 50%
  • ECOG performance status of 0 or 1

Exclusion Criteria:

  • Pregnant or lactating
  • Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
  • Prior chemotherapy within 5 years
  • Prior anthracycline therapy
  • Serious comorbid physical or psychological condition
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00146588
02-036
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Craig A. Bunnell, MD, MPH, Dana-Farber Cancer Institute
Craig A. Bunnell, MD, MPH
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Pharmacia
Principal Investigator: Craig Bunnell, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2014

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