Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT01231802
Status:
UNKNOWN
Last Update Posted:
2012-07-17
First Post:
2010-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C073482', 'term': 'eniluracil'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2010-10-27', 'studyFirstSubmitQcDate': '2010-10-29', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '7.5 months'}], 'secondaryOutcomes': [{'measure': 'To compare the tolerability and toxicity of orally administered eniluracil/5 FU/leucovorin regimen vs. capecitabine monotherapy', 'timeFrame': '7.5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34037241', 'type': 'DERIVED', 'citation': 'Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic (Stage IV) adenocarcinoma of the breast\n* Prior exposure to anthracyclines either in the neoadjuvant/adjuvant setting, or as treatment for metastatic disease\n* Either evidence of a recurrence or development of metastatic disease at least 12 months after the last dose of a taxane as neoadjuvant/adjuvant therapy, or evidence of disease progression while receiving a taxane for metastatic disease\n* ECOG Performance Status of 0 or 1\n* Measurable disease according to RECIST 1.1 Criteria\n* Adequate renal, hematologic, and hepatic function\n* Negative pregnancy test and willing to use effective contraception\n* Willing to avoid any other dose or form (iv, oral, or topical) of 5 FU or related derivatives for 8 weeks following the last dose of eniluracil\n* Willing to be closely monitored for changes in coagulation parameters (prothrombin time and/or international normalized ratio \\[INR\\] values) if receiving concomitant warfarin\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Prior treatment with capecitabine\n* More than one prior chemotherapy regimen for metastatic disease\n* Prior radiation must not have included ≥ 30% of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was \\< 30%, then a minimum interval of 6 weeks must be allowed between the last radiation treatment and administration of either study arm.\n* Currently receiving anti-cancer therapy\n* Residual ≥ Grade 2 clinically significant side effects (excluding alopecia) associated with prior radiotherapy, chemotherapy, and investigational treatments\n* Unstable CNS metastases. However, subjects that are asymptomatic and off systemic steroids and anticonvulsants for at least 3 months are not excluded.\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, ulcerative colitis, recent history of GI bleeding or perforation\n* History of other malignancy, except subjects who have been disease-free for 5 years or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma\n* Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety\n* Known history or clinical evidence of leptomeningeal carcinomatosis\n* Active or uncontrolled infection\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent\n* Known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart failure\n* Concurrent treatment with an investigational agent\n* Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication\n* Taking phenytoin\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil, leucovorin, or any excipients\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency"}, 'identificationModule': {'nctId': 'NCT01231802', 'briefTitle': 'Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adherex Technologies, Inc.'}, 'officialTitle': 'A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'AHX-03-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Eniluracil/5-FU/Leucovorin', 'description': 'Arm 1: (weekly, 28-day cycle): Approximately eighty subjects will orally self-administer eniluracil approximately 13 hr (range of 11-16 hr) before receiving 5 FU and leucovorin. The next day they will orally self-administer 5-FU and leucovorin. On the third day, they will orally self-administer leucovorin. The regimen is taken once per week for three consecutive weeks followed by one-week off-treatment.', 'interventionNames': ['Drug: Eniluracil', 'Drug: 5-Fluorouracil', 'Drug: Leucovorin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Capecitabine', 'description': 'Arm 2: (bid daily, 21-day cycle): Approximately sixty subjects will self-administer oral capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment', 'interventionNames': ['Drug: Capecitabine']}], 'interventions': [{'name': 'Eniluracil', 'type': 'DRUG', 'description': 'Eniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, \\& 15', 'armGroupLabels': ['Arm 1: Eniluracil/5-FU/Leucovorin']}, {'name': '5-Fluorouracil', 'type': 'DRUG', 'description': '5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, \\& 16', 'armGroupLabels': ['Arm 1: Eniluracil/5-FU/Leucovorin']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'Leucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, \\& 17', 'armGroupLabels': ['Arm 1: Eniluracil/5-FU/Leucovorin']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment', 'armGroupLabels': ['Arm 2: Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Methodist Hospital Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '163045', 'city': 'Arkhangelsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Arkhangelsk Regional Clinical Oncology Center', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '454087', 'city': 'Chelyabinsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Clinical Oncology', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Krasnodar', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Clinical Oncology Center #1', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Moscow Hertzen Oncology Research Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Russian Oncological Research Center n.s. Blokhin', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Orenburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Orenburg Regional Clinical Oncology Center', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'city': 'Pyatigorsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Pyatigorsk Oncology Center', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'city': 'Republic of Karelia', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Republic Oncology Center'}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'City Clinical Oncology Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Laboratory of Thoracic Oncology of Research Institute of Pulmonary at St. Petersburg State Medical University n.a. I.P. Pavlov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Leningrad Regional Oncology Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Road Clinical Hospital of the Russian Railways', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '354057', 'city': 'Sochi', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Oncology Center No. 2 Krasnodar Regional Healthcare Dept', 'geoPoint': {'lat': 43.59699, 'lon': 39.72477}}, {'city': 'Stavropol', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Stavropol Regional Clinical Oncology Center', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}], 'centralContacts': [{'name': 'Gray Kirby, PharmD', 'role': 'CONTACT', 'email': 'kirbyg@adherex.com', 'phone': '919-614-3839'}, {'name': 'Anne McKay', 'role': 'CONTACT', 'email': 'mckaya@adherex.com', 'phone': '919-949-2987'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adherex Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gray Kirby/Clinical Project Manager', 'oldOrganization': 'Adherex Technologies, Inc.'}}}}