Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer

Thank you

Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Craig Bunnell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

02-036

NCT ID:

NCT00146588

Start Date:

April 2002

Completion Date:

December 2004

Related Keywords:

  • Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Breast cancer
  • cytoxan
  • epirubicin
  • capecitabine
  • Breast Neoplasms

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-Farber Cancer Center Boston, Massachusetts  02115