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A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer


- Compare the objective response rate in women with advanced or metastatic breast cancer
treated with two dose levels of capecitabine.

- Compare the duration of response, time to progression, time to treatment failure,
survival, incidence of adverse events, and time to onset of the adverse experience in
patients treated with this drug.

- Compare the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs
no). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14.

- Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14.

In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

Quality of life is assessed at baseline, at the end of the third and sixth courses, and at
completion of therapy.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study within 9 months.

Inclusion Criteria


- Histologically and/or cytologically confirmed breast cancer

- Advanced and/or metastatic disease

- At least 1 measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- No CNS metastases

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status:

- Not specified

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 12 weeks


- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

- Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases
present OR 10 times ULN if bone metastases present)

- No hepatitis


- Creatinine no greater than 1.5 times ULN

- Creatinine clearance at least 50 mL/min


- No clinically significant cardiac disease

- No congestive heart failure

- No symptomatic coronary artery disease

- No cardiac arrhythmias poorly controlled with medication

- No myocardial infarction within the past 12 months even if adequately controlled with


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No severe pain inadequately controlled by analgesics

- No prior severe and unexpected reaction to fluoropyrimidine therapy

- No known hypersensitivity to fluorouracil

- No impaired physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome

- No inability to swallow tablets

- No history of uncontrolled seizures, central nervous system disorder, or psychiatric
disability that would preclude study participation

- No serious uncontrolled infection


Biologic therapy:

- Not specified


- At least 2 but no more than 3 prior chemotherapy regimens

- At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as
adjuvant therapy or for advanced and/or metastatic disease

Endocrine therapy:

- Not specified


- No prior radiotherapy to target lesions unless there is evidence of new disease
within the irradiated field

- No concurrent radiotherapy


- No prior organ allografts


- At least 4 weeks since prior investigational drug

- No concurrent enrollment on other investigational study

- No other concurrent anticancer agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Sandy Marcus

Investigator Role:

Study Chair

Investigator Affiliation:

Pharmatech Oncology


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



Logan Regional Hospital Logan, Utah  84321
Oncology Clinic, P.C. Colorado Springs, Colorado  80909
Charleston Hematology-Oncology, P.A. Charleston, South Carolina  29403
Medical Oncology Care Associates Orange, California  92668
Family Cancer Center Collierville, Tennessee  38017
Maryland Hematology/Oncology Associates Baltimore, Maryland  21236
Antelope Valley Hospital Lancaster, California  93534
California Cancer Medical Center West Covina, California  91790
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie Port Saint Lucie, Florida  34952
North Florida Cancer Center St. Augustine, Florida  32086