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An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma


Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma


OBJECTIVES: I. Determine the safety, response rate, and efficacy of combination therapy with
paclitaxel and capecitabine as first or second line therapy in women with metastatic breast
cancer.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1
and capecitabine orally twice daily on days 1-14. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity. Patients are followed for survival
status every 3 months upon completion of treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast
cancer Bidimensionally measurable disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 75 Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: ANC at
least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times
upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Eligible patients
may have received prior chemotherapy in metastatic or adjuvant setting with the following
exceptions: At least 12 months since prior fluoropyrimidine therapy At least 12 months
since prior taxane therapy Only 1 previous chemotherapeutic regimen in the metastatic
setting Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William J. Gradishar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067869

NCT ID:

NCT00005649

Start Date:

July 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

PPD DevelopmentWilmington, North Carolina  28412