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Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma

Phase 2
18 Years
Not Enrolling
Breast Cancer, Metastatic Cancer

Thank you

Trial Information

Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma



- Determine the efficacy of capecitabine and pegylated interferon alfa-2a, in terms of
6-month neurologic progression-free rate, in patients with recurrent or progressive
brain metastases secondary to breast cancer.


- Determine the toxicity spectrum of this regimen in these patients.

- Determine the time to neurologic progression and overall survival of patients treated
with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral capecitabine twice daily on days 1-14 and pegylated interferon alfa-2a
subcutaneously on days 1, 8, and 15. Treatment repeats every 3 weeks for at least 6 months
in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 38-98 patients will be accrued for this study within 2 years.

Inclusion Criteria


- Histologically or cytologically confirmed breast cancer that metastasized to the
brain, meeting all of the following criteria:

- Must have ≥ 1 inoperable brain metastases, meeting 1 of the following criteria:

- Progressive or recurrent disease after prior whole-brain or stereotactic

- Ineligible for OR unwilling to be treated with radiotherapy

- At least 1 unidimensionally measurable brain metastasis by enhanced MRI within
the past 21 days

- No progression or development of central nervous system (CNS) metastasis during
prior treatment with capecitabine, fluorouracil, interferon alfa, or interferon

- Systemic (i.e., outside the CNS system) cancer must be stable

- No progressive disease (e.g., liver, lymphangitic, or lung metastases)

- Hormone receptor status:

- Not specified



- 18 and over


- Male or female

Menopausal status

- Not specified

Performance status

- Karnofsky 70-100%

Life expectancy

- More than 12 weeks


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 mg/dL

- No history of idiopathic thrombocytopenic purpura

- No known uncontrolled coagulopathy

- No increased risk for anemia (e.g., thalassemia or spherocytosis)

- No medically problematic anemia


- aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤
2.5 times upper limit of normal (ULN) (5 times ULN for patients with concurrent liver
metastases )

- Bilirubin ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN for patients with concurrent liver
metastases; 10 times ULN for patients with concurrent bone metastases)


- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 30 mL/min


- No congestive heart failure

- No symptomatic coronary artery disease

- No medically uncontrolled arrhythmia

- No other clinically significant cardiac disease

- No myocardial infarction within the past 12 months


- No history of inflammatory bowel disease

- Must have intact upper gastrointestinal tract

- Able to swallow tablets

- No malabsorption syndrome

- No history of gastrointestinal bleeding


- No prior unanticipated severe reaction to fluoropyrimidine therapy, interferon,
pegylated interferon, or a pegylated moiety

- No known sensitivity to fluorouracil

- No serious uncontrolled infection

- No history of immunologically mediated disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No known dihydropyrimidine dehydrogenase deficiency

- No history of depression characterized by a suicide attempt

- No history of hospitalization for psychiatric disease

- No history of other severe psychiatric disease

- No prior disability as a result of psychiatric disease

- No history of clinically significant psychiatric disability that would preclude study

- No other malignancy within the past 5 years except cured nonmelanoma skin cancer or
treated carcinoma in situ of the cervix

- No uncontrolled thyroid dysfunction (e.g., thyroid-stimulating hormone not in normal

- No evidence of severe retinopathy (e.g., Cytomegalovirus (CMV) retinitis or macular

- No clinically relevant ophthalmologic disorders due to diabetes or hypertension

- No other serious uncontrolled medical conditions that would preclude study


Biologic therapy

- See Disease Characteristics

- At least 3 months since prior interferon alfa or interferon beta


- See Disease Characteristics

- At least 3 months since prior capecitabine or fluorouracil

Endocrine therapy

- Concurrent hormonal agents (e.g., tamoxifen, raloxifene, or anastrazole) for breast
cancer allowed


- See Disease Characteristics


- More than 4 weeks since prior major surgery and recovered


- More than 4 weeks since prior participation in another investigational drug study

- At least 4 weeks since prior and no concurrent brivudine or sorivudine

- No concurrent cimetidine

- No other concurrent investigational or commercial agents or therapies for this

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Neurologic progression-free survival rate at 6 months

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Morris D. Groves, MD, JD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

November 2006

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • tumors metastatic to brain
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



CCOP - WichitaWichita, Kansas  67214-3882
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Grand RapidsGrand Rapids, Michigan  49503
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009