Nctid:
NCT00001384
Payload:
{"FullStudy"=>{"Rank"=>474273, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000001943", "ConditionMeshTerm"=>"Breast Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000001941", "ConditionAncestorTerm"=>"Breast Diseases"}, {"ConditionAncestorId"=>"D000012871", "ConditionAncestorTerm"=>"Skin Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M4910", "ConditionBrowseLeafName"=>"Breast Neoplasms", "ConditionBrowseLeafAsFound"=>"Breast Cancer", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4908", "ConditionBrowseLeafName"=>"Breast Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15364", "ConditionBrowseLeafName"=>"Skin Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000017239", "InterventionMeshTerm"=>"Paclitaxel"}, {"InterventionMeshId"=>"D000003520", "InterventionMeshTerm"=>"Cyclophosphamide"}, {"InterventionMeshId"=>"D000004317", "InterventionMeshTerm"=>"Doxorubicin"}, {"InterventionMeshId"=>"C000506643", "InterventionMeshTerm"=>"Liposomal doxorubicin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000972", "InterventionAncestorTerm"=>"Antineoplastic Agents, Phytogenic"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000050257", "InterventionAncestorTerm"=>"Tubulin Modulators"}, {"InterventionAncestorId"=>"D000050256", "InterventionAncestorTerm"=>"Antimitotic Agents"}, {"InterventionAncestorId"=>"D000050258", "InterventionAncestorTerm"=>"Mitosis Modulators"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000007166", "InterventionAncestorTerm"=>"Immunosuppressive Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018501", "InterventionAncestorTerm"=>"Antirheumatic Agents"}, {"InterventionAncestorId"=>"D000018906", "InterventionAncestorTerm"=>"Antineoplastic Agents, Alkylating"}, {"InterventionAncestorId"=>"D000000477", "InterventionAncestorTerm"=>"Alkylating Agents"}, {"InterventionAncestorId"=>"D000019653", "InterventionAncestorTerm"=>"Myeloablative Agonists"}, {"InterventionAncestorId"=>"D000000903", "InterventionAncestorTerm"=>"Antibiotics, Antineoplastic"}, {"InterventionAncestorId"=>"D000059005", "InterventionAncestorTerm"=>"Topoisomerase II Inhibitors"}, {"InterventionAncestorId"=>"D000059003", "InterventionAncestorTerm"=>"Topoisomerase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M19227", "InterventionBrowseLeafName"=>"Paclitaxel", "InterventionBrowseLeafAsFound"=>"Based", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M6417", "InterventionBrowseLeafName"=>"Cyclophosphamide", "InterventionBrowseLeafAsFound"=>"Injection", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1945", "InterventionBrowseLeafName"=>"Lenograstim", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M231", "InterventionBrowseLeafName"=>"Albumin-Bound Paclitaxel", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7182", "InterventionBrowseLeafName"=>"Doxorubicin", "InterventionBrowseLeafAsFound"=>"Antibody", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M227283", "InterventionBrowseLeafName"=>"Liposomal doxorubicin", "InterventionBrowseLeafAsFound"=>"Antibody", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M25887", "InterventionBrowseLeafName"=>"Tubulin Modulators", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25886", "InterventionBrowseLeafName"=>"Antimitotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9902", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20294", "InterventionBrowseLeafName"=>"Antirheumatic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20632", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Alkylating", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3510", "InterventionBrowseLeafName"=>"Alkylating Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3914", "InterventionBrowseLeafName"=>"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"35"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"May 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"April 2000", "CompletionDateStruct"=>{"CompletionDate"=>"February 2001"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["14-Day Cycle", "Dose Intensity", "Filgrastim", "Lymph Node Positive", "Non-Cross Resistant"]}, "ConditionList"=>{"Condition"=>["Breast Cancer", "Breast Neoplasms"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"3806165", "ReferenceType"=>"background", "ReferenceCitation"=>"Jones RB, Holland JF, Bhardwaj S, Norton L, Wilfinger C, Strashun A. A phase I-II study of intensive-dose adriamycin for advanced breast cancer. J Clin Oncol. 1987 Feb;5(2):172-7. doi: 10.1200/JCO.1987.5.2.172."}, {"ReferencePMID"=>"7060037", "ReferenceType"=>"background", "ReferenceCitation"=>"Wheeler RH, Ensminger WD, Thrall JH, Anderson JL. High-dose doxorubicin: an exploration of the dose-response curve in human neoplasia. Cancer Treat Rep. 1982 Mar;66(3):493-8."}, {"ReferencePMID"=>"6387060", "ReferenceType"=>"background", "ReferenceCitation"=>"Hryniuk W, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol. 1984 Nov;2(11):1281-8. doi: 10.1200/JCO.1984.2.11.1281. No abstract available."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.", "DetailedDescription"=>"This is a pilot feasibility trial of AC (Adriamycin® (Registered Trademark), cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol® (Registered Trademark) (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Recently diagnosed patients with histologically proven Stage II breast cancer who have 4 or more positive lymph nodes or patients with stage III breast cancer are eligible for this study.\n\nPatients will be eligible for study either before or after receiving adjuvant radiation therapy.\n\nPatients with stage III disease will be eligible to receive this regimen as neo-adjuvant chemotherapy or as adjuvant therapy if surgery was performed prior to patient referral.\n\nPatients must be previously untreated with chemotherapy.\n\nThere must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years. Patients with a prior history of lower stage contralateral breast cancer, treated with surgery, and/or radiation, but not chemotherapy, are eligible for this study.\n\nPerformance status (Karnofsky scale) must be greater than 70; ECOG 0 to 2.\n\nAbsolute granulocyte count greater than 1500 per microliter and platelet count greater than 100,000 per mm(3).\n\nLiver function tests (SGOT, and total bilirubin) should be less than 2X upper limits of normal. Serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml per min.\n\nThe patient must be able to give an informed consent, and to return to NCI for treatment and adequate follow-up for the period the protocol requires.\n\nPatients must be greater than or equal to 18 years of age.\n\nPatients and/or their partners must be willing to practice a non-hormonal method of contraception during therapy and for 6 months following therapy.\n\nPatients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol are excluded.\n\nPatients must have a normal ejection fraction by MUGA scan and have no angina. Patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease.\n\nNo patients with a history of symptomatic CNS disease.\n\nNo patients with allergy to any study medication.\n\nNo pregnant or lactating women.\n\nPatients with bleeding disorders are ineligible for study entry as are patients requiring chronic anticoagulation."}, "IdentificationModule"=>{"NCTId"=>"NCT00001384", "BriefTitle"=>"A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients", "OrgStudyIdInfo"=>{"OrgStudyId"=>"940145"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"94-C-0145"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Adriamycin", "InterventionType"=>"Drug"}, {"InterventionName"=>"cyclophosphamide", "InterventionType"=>"Drug"}, {"InterventionName"=>"G-CSF", "InterventionType"=>"Drug"}, {"InterventionName"=>"paclitaxel", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}