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A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
59 Years
Not Enrolling
Both
Breast Cancer

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Trial Information

A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer


OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in
combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast
cancer. II. Determine the response rate of these patients to this treatment regimen. III.
Determine the median time to treatment failure in these patients with this treatment
regimen. IV. Determine the incidence of cardiac toxicity in these patients with this
treatment regimen. V. Assess the quality of life in these patients.

OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab
(Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2;
and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 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 6 patients
experience dose limiting toxicities. Once the MTD is determined, additional patients are
accrued. Quality of life is assessed at baseline and after 3 courses of treatment.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation
portion of this study. A total of 28-41 patients will be accrued for the phase II portion of
this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic
disease HER2 overexpressing tumor (2+ or 3+) Bidimensionally measurable or evaluable
disease Hormone receptor status: Estrogen receptor positive or negative

PATIENT CHARACTERISTICS: Age: 18 to 59 Menopausal status: Not specified Performance
status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count
at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5
times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection
fraction at least 50% by MUGA No history of congestive heart failure No uncontrolled
cardiac arrhythmias Other: No other prior malignancy except squamous cell or basal cell
carcinoma of the skin, noninvasive ductal carcinoma of the breast, or cervical dysplasia
No prior motor or sensory neuropathy grade 2 or higher Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior trastuzumab (Herceptin) No concurrent
hematopoietic growth factors Chemotherapy: No prior chemotherapy for metastatic disease
Prior adjuvant chemotherapy allowed (including regimens containing doxorubicin) No prior
paclitaxel, 24 hour infusion fluorouracil, or capecitabine Endocrine therapy: Not
specified Radiotherapy: No prior radiotherapy to 50% or more of the bone marrow Surgery:
Not specified Other: No other concurrent experimental drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Frances A. Collichio, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LCCC 9904

NCT ID:

NCT00006108

Start Date:

August 1999

Completion Date:

July 2002

Related Keywords:

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

Name

Location
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295