Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

August 24, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.

Change History

Complete list of historical versions of study NCT00146588 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

Official Title ^ICMJE

A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer

Brief Summary

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.

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer

Intervention ^ICMJE

Drug: Cyclophosphamide
Drug: Epirubicin
Drug: Capecitabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2008

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00146588

Responsible Party

Craig Bunnell, MD, Dana-Farber Cancer Institute

Study ID Numbers ^ICMJE

02-036

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Pharmacia

Investigators ^ICMJE

Principal Investigator:

Craig Bunnell, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

August 2009

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