Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

Sponsor

Craig A. Bunnell, MD, MPH (Other)

Overall Status

Completed

CT.gov ID

NCT00146588

Collaborator

Dana-Farber Cancer Institute (Other), Massachusetts General Hospital (Other), Brigham and Women's Hospital (Other), Beth Israel Deaconess Medical Center (Other), Pharmacia (Industry)

Enrollment

Locations

Duration (Months)

27.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer	Drug: Cyclophosphamide Drug: Epirubicin Drug: Capecitabine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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