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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

Page last updated: August 23, 2015

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