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Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Metastatic Cancer

Intervention: PEG-interferon alfa-2a (Biological); Capecitabine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Morris D. Groves, MD, JD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center


RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pegylated interferon alfa-2a may interfere with the growth of tumor cells. Giving capecitabine together with pegylated interferon alfa-2a may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with pegylated interferon alfa-2a works in treating patients with recurrent or progressive brain metastases due to breast cancer.

Clinical Details

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

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

Primary outcome: Neurologic progression-free survival rate at 6 months

Secondary outcome:

Time to neurologic progression

Overall survival

Tumor response (complete response and partial response)


Detailed description: OBJECTIVES: Primary

- 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. Secondary

- 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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 beta

- 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) Renal

- 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

participation PRIOR CONCURRENT THERAPY: 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 Radiotherapy

- 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


Locations and Contacts

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States

Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

University of Texas M.D. Anderson CCOP Research Base, Houston, Texas 77030-4009, United States

Additional Information

Starting date: September 2005
Last updated: December 10, 2012

Page last updated: August 23, 2015

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