Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer
Intervention: Cyclophosphamide (Drug); Epirubicin (Drug); Capecitabine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Craig A. Bunnell, MD, MPH Official(s) and/or principal investigator(s): Craig Bunnell, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
Official title: A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Dana-Farber Cancer Center, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: April 2002
Last updated: March 23, 2015
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