Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT00227656
Status:
TERMINATED
Last Update Posted:
2012-12-11
First Post:
2005-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study slow to accrue.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2005-09-26', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurologic progression-free survival rate at 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Time to neurologic progression', 'timeFrame': '6 months or until disease progression'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 2 years'}, {'measure': 'Tumor response (complete response and partial response)', 'timeFrame': '6 months', 'description': 'Response Evaluation Criteria in Solid Tumors (RECIST) criteria for Target (Brain Metastasis) Lesions where Complete Response (CR): Disappearance of all target lesions; and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}, {'measure': 'Toxicity', 'timeFrame': '6 months', 'description': 'Toxicity defined as grade 3 or 4 hematologic, skin (hand and foot syndrome), or fatigue/myalgia/flu debilitation-syndrome (interferon-related) toxicities.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer', 'male breast cancer', 'tumors metastatic to brain'], 'conditions': ['Breast Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* Determine the toxicity spectrum of this regimen in these patients.\n* Determine the time to neurologic progression and overall survival of patients treated with this regimen.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients 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.\n\nPROJECTED ACCRUAL: A total of 38-98 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed breast cancer that metastasized to the brain, meeting all of the following criteria:\n\n * Must have ≥ 1 inoperable brain metastases, meeting 1 of the following criteria:\n\n * Progressive or recurrent disease after prior whole-brain or stereotactic radiotherapy\n * Ineligible for OR unwilling to be treated with radiotherapy\n * At least 1 unidimensionally measurable brain metastasis by enhanced MRI within the past 21 days\n * No progression or development of central nervous system (CNS) metastasis during prior treatment with capecitabine, fluorouracil, interferon alfa, or interferon beta\n* Systemic (i.e., outside the CNS system) cancer must be stable\n\n * No progressive disease (e.g., liver, lymphangitic, or lung metastases)\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Male or female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* More than 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 10 mg/dL\n* No history of idiopathic thrombocytopenic purpura\n* No known uncontrolled coagulopathy\n* No increased risk for anemia (e.g., thalassemia or spherocytosis)\n* No medically problematic anemia\n\nHepatic\n\n* 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 )\n* Bilirubin ≤ 1.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN for patients with concurrent liver metastases; 10 times ULN for patients with concurrent bone metastases)\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN OR\n* Creatinine clearance ≥ 30 mL/min\n\nCardiovascular\n\n* No congestive heart failure\n* No symptomatic coronary artery disease\n* No medically uncontrolled arrhythmia\n* No other clinically significant cardiac disease\n* No myocardial infarction within the past 12 months\n\nGastrointestinal\n\n* No history of inflammatory bowel disease\n* Must have intact upper gastrointestinal tract\n* Able to swallow tablets\n* No malabsorption syndrome\n* No history of gastrointestinal bleeding\n\nImmunologic\n\n* No prior unanticipated severe reaction to fluoropyrimidine therapy, interferon, pegylated interferon, or a pegylated moiety\n* No known sensitivity to fluorouracil\n* No serious uncontrolled infection\n* No history of immunologically mediated disease\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after completion of study treatment\n* No known dihydropyrimidine dehydrogenase deficiency\n* No history of depression characterized by a suicide attempt\n* No history of hospitalization for psychiatric disease\n* No history of other severe psychiatric disease\n* No prior disability as a result of psychiatric disease\n* No history of clinically significant psychiatric disability that would preclude study compliance\n* No other malignancy within the past 5 years except cured nonmelanoma skin cancer or treated carcinoma in situ of the cervix\n* No uncontrolled thyroid dysfunction (e.g., thyroid-stimulating hormone not in normal range)\n* No evidence of severe retinopathy (e.g., Cytomegalovirus (CMV) retinitis or macular degeneration)\n* No clinically relevant ophthalmologic disorders due to diabetes or hypertension\n* No other serious uncontrolled medical conditions that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* At least 3 months since prior interferon alfa or interferon beta\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 3 months since prior capecitabine or fluorouracil\n\nEndocrine therapy\n\n* Concurrent hormonal agents (e.g., tamoxifen, raloxifene, or anastrazole) for breast cancer allowed\n\nRadiotherapy\n\n* See Disease Characteristics\n\nSurgery\n\n* More than 4 weeks since prior major surgery and recovered\n\nOther\n\n* More than 4 weeks since prior participation in another investigational drug study\n* At least 4 weeks since prior and no concurrent brivudine or sorivudine\n* No concurrent cimetidine\n* No other concurrent investigational or commercial agents or therapies for this malignancy'}, 'identificationModule': {'nctId': 'NCT00227656', 'briefTitle': 'Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma', 'orgStudyIdInfo': {'id': '2004-0727'}, 'secondaryIdInfos': [{'id': 'MDA-2004-0727'}, {'id': 'NCI-6810'}, {'id': 'CDR0000443592', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capecitabine + PEG-interferon alfa-2a', 'description': '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.', 'interventionNames': ['Biological: PEG-interferon alfa-2a', 'Drug: Capecitabine']}], 'interventions': [{'name': 'PEG-interferon alfa-2a', 'type': 'BIOLOGICAL', 'otherNames': ['PEGSYS', 'Interferon-alfa-2a', 'Interferon alpha 2a recombinant', 'Pegylated interferon alfa-2a'], 'description': '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.', 'armGroupLabels': ['Capecitabine + PEG-interferon alfa-2a']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': '1000 mg/m\\^2 twice daily during first 14 days of each 3-week cycle (2 weeks on, 1 week rest).', 'armGroupLabels': ['Capecitabine + PEG-interferon alfa-2a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Grand Rapids', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Cancer Research for the Ozarks', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas M.D. Anderson CCOP Research Base', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Morris D. Groves, MD, JD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}