A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer
18 Years
70 Years
Female
Breast Cancer
Trial Information
A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer
OBJECTIVES: I. Determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and
epirubicin in women with locally advanced or inflammatory or large operable breast cancer.
II. Determine the maximum tolerated dose of this regimen in this patient population.
OUTLINE: This is a multicenter dose escalation study of capecitabine. Patients receive
neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily
on days 1-14. Treatment continues every 21 days for a maximum of 6 courses in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
limiting toxicity.
PROJECTED ACCRUAL: A total of 3-33 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the breast
Locally advanced or inflammatory disease (T4, any N or any T, N2 or N3 or T4d) OR Large
operable disease (large T2 or T3 for which tumor shrinkage is needed) No distant
metastasis on chest x-ray, liver ultrasound, or bone scan except for ipsilateral
supraclavicular nodes No abnormal bone scintigrams that cannot be confirmed as benign
Hormone Receptor Status Not specified
PATIENT CHARACTERISTICS: Age: 18 to 70 Sex: Female Menopausal status: Not specified
Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count
at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than
1.25 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine
no greater than 1.5 times ULN Cardiovascular: LVEF normal by echocardiography or MUGA
Other: Not pregnant or nursing Fertile patients must use effective contraception No other
serious uncontrolled illnesses No uncontrolled psychiatric or addictive disorders No other
concurrent or prior malignancy within the past 5 years except adequately treated basal or
squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Herve Bonnefoi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Cantonal Universitaire de Geneve
Authority:
United States: Federal Government
Study ID:
EORTC-10991
NCT ID:
NCT00008034
Start Date:
February 2000
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- inflammatory breast cancer
- Breast Neoplasms
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