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

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Massachusetts General Hospital Brigham and Women's Hospital Beth Israel Deaconess Medical Center Pharmacia
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00146588

Purpose

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	Intervention
Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer	Drug: Cyclophosphamide Drug: Epirubicin Drug: Capecitabine

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Epirubicin hydrochloride Epirubicin Capecitabine

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ]

Enrollment:	55
Study Start Date:	April 2002
Estimated Study Completion Date:	September 2008
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146588

Locations

United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Pharmacia

Investigators

Principal Investigator:

Craig Bunnell, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Craig Bunnell, MD )
Study ID Numbers:	02-036
Study First Received:	September 6, 2005
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00146588 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Breast cancer
cytoxan
epirubicin
capecitabine

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Cyclophosphamide
Antibiotics, Antineoplastic

Epirubicin
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009