Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-21 @ 12:09 PM
Study NCT ID:
NCT00007904
Status:
COMPLETED
Last Update Posted:
2012-10-02
First Post:
2001-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], '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': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-28', 'studyFirstSubmitDate': '2001-01-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide', 'timeFrame': '9 weeks', 'description': 'Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3 given concurrently with cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3. Patients will be observed in the outpatient treatment area during the first 2 hours of the paclitaxel infusion for allergic reactions. Epinephrine, hydrocortisone, and IV antihistamine will be available.'}, {'measure': 'To determine the incidence of febrile neutropenia with the first cycle of therapy.', 'timeFrame': '3 weeks', 'description': 'A specific objective of this trial is to estimate the incidence of febrile neutropenia. The observed incidence of febrile neutropenia with the first cycle of cyclophosphamide and paclitaxel, as well as the observed number of days of grade ¾ neutropenia during the first treatment cycle, will be reported along with 95% confidence intervals.'}], 'secondaryOutcomes': [{'measure': 'To determine days of neutrophil counts below 500/uL on this regimen during the first treatment cycle.', 'timeFrame': 'after 1st cycle (3 weeks)'}, {'measure': 'To evaluate dose delays and dose reductions of this regimen.', 'timeFrame': 'at 7 cycles (21 weeks)'}, {'measure': 'To determine disease-free and overall survival of this regimen.', 'timeFrame': '5 yrs after treatment'}, {'measure': 'Quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire', 'timeFrame': '6 months after treatment', 'description': 'Quality of life will be assessed using the FACT-B instrument. Quality of life will be assessed at the following timepoints: Cycle 1 day 1, Cycle 1 day 4, Cycle 2 day 1, on the final day of adriamycin, and 6 months after treatment is completed.'}, {'measure': 'Correlation of Her2/neu overexpression with disease-free and overall survival', 'timeFrame': '5 yrs after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'male breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/results?term=cwru1100', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving \\> 4 lymph nodes.\n* Determine the incidence of febrile neutropenia in these patients during the first course of therapy.\n* Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194.\n* Determine the disease-free and overall survival of patients treated with this regimen.\n* Evaluate the quality of life of these patients.\n* Correlate HER-2/neu overexpression with disease-free and overall survival in these patients.\n\nOUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.\n\nPatients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy.\n\nBeginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.\n\nQuality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment.\n\nPatients are followed every 3 months for 2 years and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage II or IIIA breast cancer\n\n * At least 5 axillary lymph nodes\n * No T4 or N3 disease\n* No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation\n* No more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection\n\n * Negative surgical margins\n* Hormone receptor status:\n\n * Hormone receptor status known\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* ECOG 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,500/mm\\^3\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT no greater than 1.5 times ULN\n* Alkaline phosphatase no greater than 1.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No poorly controlled ischemic heart disease or congestive heart failure\n\nPulmonary:\n\n* No severe chronic obstructive or restrictive pulmonary disease\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No severe diabetes mellitus\n* No other severe concurrent medical or psychiatric illness that would preclude study participation\n* No other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00007904', 'briefTitle': 'Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Than or Equal to 10 Lymph Nodes', 'orgStudyIdInfo': {'id': 'CWRU1100'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': '05-00-23', 'type': 'OTHER', 'domain': 'University Hospitals IRB'}, {'id': 'NCI-G00-1877'}, {'id': 'CWRU1100', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'NCI-2010-01068', 'type': 'OTHER', 'domain': 'NCI/CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Combination Chemotherapy', 'description': 'Paclitaxel IV continuously over 72 hours on days 1-3 and cyclophosphamide IV on days 1-3. Filgrastim subcutaneously (SC) beginning on day 5 and continuing until blood counts recover or pegfilgrastim SC on day 5. Treatment repeats every 21 days for 3 courses. Then doxorubicin hydrochloride IV on day 1 and filgrastim SC beginning on day 2 and continuing until blood counts recover or pegfilgrastim SC on day 2. Treatment repeats every 21 days for 4 courses. Patients with hormone-receptor positive tumors receive oral tamoxifen citrate or oral anastrozole daily for 5 years following chemotherapy. Beginning 3-6 weeks after completion of chemotherapy, patients undergo radiation therapy 5 days a week for 6-7 weeks.', 'interventionNames': ['Biological: filgrastim', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: paclitaxel', 'Drug: tamoxifen citrate', 'Procedure: adjuvant therapy', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['G-CSF, Neupogen®', 'recominant-methionyl human granulocyte-colony stimulating factor', 'granulocyte colony stimulating factor', 'r-methHuG-CSF'], 'description': 'Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC \\> 10,000/uL x1 day after the nadir cycles 1-3.', 'armGroupLabels': ['Arm A: Combination Chemotherapy']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan®', 'CTX', 'CPM', 'Neosar®'], 'description': 'cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3', 'armGroupLabels': ['Arm A: Combination Chemotherapy']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'description': 'Patients then receive doxorubicin IV on day 1.', 'armGroupLabels': ['Arm A: Combination Chemotherapy']}, {'name': 'paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol®'], 'description': 'Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3', 'armGroupLabels': ['Arm A: Combination Chemotherapy']}, {'name': 'tamoxifen citrate', 'type': 'DRUG', 'description': 'tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed', 'armGroupLabels': ['Arm A: Combination Chemotherapy']}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'description': 'Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.', 'armGroupLabels': ['Arm A: Combination Chemotherapy']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.', 'armGroupLabels': ['Arm A: Combination Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-LUICC', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44122', 'city': 'Orange', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Chagrin Highlands', 'geoPoint': {'lat': 41.44978, 'lon': -81.48067}}], 'overallOfficials': [{'name': 'Brenda W. Cooper, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}