Status:
TERMINATED
Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 interfer...
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 m...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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 radiotherapy
- 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
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Male or female
- Menopausal status
- Not specified
- Performance status
- Karnofsky 70-100%
- Life expectancy
- More than 12 weeks
- Hematopoietic
- 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
- Hepatic
- 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
- Cardiovascular
- 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
- Gastrointestinal
- No history of inflammatory bowel disease
- Must have intact upper gastrointestinal tract
- Able to swallow tablets
- No malabsorption syndrome
- No history of gastrointestinal bleeding
- Immunologic
- 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
- Other
- 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 compliance
- 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 range)
- No evidence of severe retinopathy (e.g., Cytomegalovirus (CMV) retinitis or macular degeneration)
- 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
- Chemotherapy
- 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
- Surgery
- More than 4 weeks since prior major surgery and recovered
- Other
- 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 malignancy
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00227656
Start Date
September 1 2005
End Date
November 1 2006
Last Update
December 11 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
2
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
3
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
4
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009