Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

NCT ID: NCT00146588

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2004-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cyclophosphamide

Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.

Intervention Type: DRUG

Epirubicin

Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.

Intervention Type: DRUG

Capecitabine

Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.

Intervention Type: DRUG

Other Intervention Names

Cytoxan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Pharmacia

INDUSTRY

Sponsor Role: collaborator

Craig A. Bunnell, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Craig A. Bunnell, MD, MPH

Associate Chief Medical Officer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Craig Bunnell, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

02-036

Identifier Type: -

Identifier Source: org_study_id