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

NCT00227656 | Terminated Phase 2

• 4 other identifiers: 2004-0727MDA-2004-0727NCI-6810CDR0000443592
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Breast Cancer; Metastatic Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; male breast cancer; tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

• Neurologic progression-free survival rate at 6 months

  6 months

Secondary Outcomes (4)

• Time to neurologic progression

  6 months or until disease progression

• Overall survival

  Up to 2 years

• Tumor response (complete response and partial response)

  6 months

• Toxicity

  6 months

Study Arms (1)

Capecitabine + PEG-interferon alfa-2a

EXPERIMENTAL

Capecitabine 1000 mg/m2 orally twice daily during the first 14 days of each 3-week cycle (2 weeks on, 1 week rest), and PEG-interferon alfa-2a subcutaneously beginning at 180 mcg per week for 21 days.

Biological: PEG-interferon alfa-2a; Drug: Capecitabine

Interventions

PEG-interferon alfa-2a BIOLOGICAL

Once a week subcutaneous injection for 21 days, beginning at 180 mcg per week. Repeated for additional 21 days to begin at the same time as repeat 21 day Capecitabine cycle.

Also known as: PEGSYS, Interferon-alfa-2a, Interferon alpha 2a recombinant, Pegylated interferon alfa-2a

Capecitabine + PEG-interferon alfa-2a

Capecitabine DRUG

1000 mg/m\^2 twice daily during first 14 days of each 3-week cycle (2 weeks on, 1 week rest).

Also known as: Xeloda

Capecitabine + PEG-interferon alfa-2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Breast Neoplasms, Male; Brain Neoplasms

Interventions

peginterferon alfa-2a; Interferon alpha-2; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Morris D. Groves, MD, JD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: September 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

US (4)