Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Pharmacia
Information provided by (Responsible Party):
Craig A. Bunnell, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00146588
First received: September 6, 2005
Last updated: June 25, 2013
Last verified: March 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer

Resource links provided by NLM:


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
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Craig A. Bunnell, MD, MPH
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: Craig A. Bunnell, MD, MPH, Associate Chief Medical Officer, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00146588     History of Changes
Other Study ID Numbers: 02-036
Study First Received: September 6, 2005
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Breast cancer
cytoxan
epirubicin
capecitabine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Capecitabine
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 29, 2014