Nctid:
NCT00001426
Payload:
{"FullStudy"=>{"Rank"=>497956, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000010051", "ConditionMeshTerm"=>"Ovarian Neoplasms"}, {"ConditionMeshId"=>"D000077216", "ConditionMeshTerm"=>"Carcinoma, Ovarian Epithelial"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000004701", "ConditionAncestorTerm"=>"Endocrine Gland Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000010049", "ConditionAncestorTerm"=>"Ovarian Diseases"}, {"ConditionAncestorId"=>"D000000291", "ConditionAncestorTerm"=>"Adnexal Diseases"}, {"ConditionAncestorId"=>"D000005831", "ConditionAncestorTerm"=>"Genital Diseases, Female"}, {"ConditionAncestorId"=>"D000052776", "ConditionAncestorTerm"=>"Female Urogenital Diseases"}, {"ConditionAncestorId"=>"D000005261", "ConditionAncestorTerm"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000005833", "ConditionAncestorTerm"=>"Genital Neoplasms, Female"}, {"ConditionAncestorId"=>"D000014565", "ConditionAncestorTerm"=>"Urogenital Neoplasms"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000004700", "ConditionAncestorTerm"=>"Endocrine System Diseases"}, {"ConditionAncestorId"=>"D000006058", "ConditionAncestorTerm"=>"Gonadal Disorders"}, {"ConditionAncestorId"=>"D000002277", "ConditionAncestorTerm"=>"Carcinoma"}, {"ConditionAncestorId"=>"D000009375", "ConditionAncestorTerm"=>"Neoplasms, Glandular and Epithelial"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M12974", "ConditionBrowseLeafName"=>"Ovarian Neoplasms", "ConditionBrowseLeafAsFound"=>"Ovarian Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M1704", "ConditionBrowseLeafName"=>"Carcinoma, Ovarian Epithelial", "ConditionBrowseLeafAsFound"=>"Ovarian Cancer", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5534", "ConditionBrowseLeafName"=>"Carcinoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7863", "ConditionBrowseLeafName"=>"Endocrine Gland Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12972", "ConditionBrowseLeafName"=>"Ovarian Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3643", "ConditionBrowseLeafName"=>"Adnexal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8943", "ConditionBrowseLeafName"=>"Genital Diseases, Female", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2875", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M27093", "ConditionBrowseLeafName"=>"Female Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14127", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8399", "ConditionBrowseLeafName"=>"Female Urogenital Diseases and Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8945", "ConditionBrowseLeafName"=>"Genital Neoplasms, Female", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17315", "ConditionBrowseLeafName"=>"Urogenital Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7862", "ConditionBrowseLeafName"=>"Endocrine System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9163", "ConditionBrowseLeafName"=>"Gonadal Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12320", "ConditionBrowseLeafName"=>"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T4352", "ConditionBrowseLeafName"=>"Ovarian Cancer", "ConditionBrowseLeafAsFound"=>"Ovarian Cancer", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T4354", "ConditionBrowseLeafName"=>"Ovarian Epithelial Cancer", "ConditionBrowseLeafAsFound"=>"Ovarian Cancer", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Gland and Hormone Related Diseases", "ConditionBrowseBranchAbbrev"=>"BC19"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000017239", "InterventionMeshTerm"=>"Paclitaxel"}, {"InterventionMeshId"=>"D000003520", "InterventionMeshTerm"=>"Cyclophosphamide"}]}, "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"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M19537", "InterventionBrowseLeafName"=>"Paclitaxel", "InterventionBrowseLeafAsFound"=>"Surgery", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M6727", "InterventionBrowseLeafName"=>"Cyclophosphamide", "InterventionBrowseLeafAsFound"=>"Cycle", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M231", "InterventionBrowseLeafName"=>"Albumin-Bound Paclitaxel", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6182", "InterventionBrowseLeafName"=>"Cisplatin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M26197", "InterventionBrowseLeafName"=>"Tubulin Modulators", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M26196", "InterventionBrowseLeafName"=>"Antimitotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10212", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20604", "InterventionBrowseLeafName"=>"Antirheumatic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20942", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Alkylating", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3820", "InterventionBrowseLeafName"=>"Alkylating Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"66"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"February 3, 1995"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 7, 2013", "CompletionDateStruct"=>{"CompletionDate"=>"November 7, 2013", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"April 4, 2018", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"April 5, 2018", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"October 15, 2007", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Ovarian Cancer", "Initial Therapy", "Paclitaxel", "Cisplatin", "Cyclophosphamide"]}, "ConditionList"=>{"Condition"=>["Ovarian Neoplasm"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8751547", "ReferenceType"=>"background", "ReferenceCitation"=>"Kohn EC, Sarosy GA, Davis P, Christian M, Link CE, Ognibene FP, Sindelar WF, Jacob J, Steinberg SM, Premkumar A, Reed E. A phase I/II study of dose-intense paclitaxel with cisplatin and cyclophosphamide as initial therapy of poor-prognosis advanced-stage epithelial ovarian cancer. Gynecol Oncol. 1996 Aug;62(2):181-91. doi: 10.1006/gyno.1996.0213."}, {"ReferencePMID"=>"7541159", "ReferenceType"=>"background", "ReferenceCitation"=>"Reed E, Kohn EC, Sarosy G, Dabholkar M, Davis P, Jacob J, Maher M. Paclitaxel, cisplatin, and cyclophosphamide in human ovarian cancer: molecular rationale and early clinical results. Semin Oncol. 1995 Jun;22(3 Suppl 6):90-6."}, {"ReferencePMID"=>"8729957", "ReferenceType"=>"background", "ReferenceCitation"=>"Link CJ Jr, Sarosy GA, Kohn EC, Christian MC, Davis P, Adamo DO, Reed E. Cutaneous manifestations of Taxol therapy. Invest New Drugs. 1995;13(3):261-3. doi: 10.1007/BF00873811."}]}}, "DescriptionModule"=>{"BriefSummary"=>"A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.", "DetailedDescription"=>"A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel."}, "EligibilityModule"=>{"Gender"=>"Female", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nAll patients must have biopsy proven, newly diagnosed epithelial ovarian cancer, primary epithelial fallopian tube cancer, or peritoneal surface carcinoma. Histopathologic diagnosis must be confirmed in the pathology department of the treating institution prior to initiation of therapy. Diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute. This confirmation is not necessary prior to entering the patient onto protocol.\n\nPatients must have FIGO stage III or IV disease and will undergo attempted surgical debulking prior to the initiation of chemotherapy.\n\nPatients must be able to begin therapy within 6 weeks of staging laparotomy and should have an indwelling venous access device placed. A double lumen catheter is preferred.\n\nPerformance status of less than or equal to ECOG 2.\n\nPatients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.\n\nAll patients must be registered by calling the Orkand Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST; Eligibility criteria will be queried.\n\nEXCLUSION CRITERIA:\n\nEvidence CNS involvement (patients with normal clinical exam will not require a head CT scan or MRI).\n\nHistory of myocardial infarction or unstable dysrhythmia within 1 month of study entry.\n\nCreatinine clearance of less than 60 cc/min, ANC less than 1000/cm3, platelet count less than 1000,000/cm3.\n\nHistory of active GI bleeding within the last 30 days.\n\nPrior therapy other than surgery for this malignancy.\n\nAbnormal PT, PTT, and bilirubin. SGOT greater than or equal to 3 times the upper limit of normal.\n\nPrevious history of invasive malignancy.\n\nPatients with ureteral obstruction must have this corrected prior to starting therapy.\n\nPatients with germ cell, mixed Muellerian and borderline histologies are specifically excluded."}, "IdentificationModule"=>{"NCTId"=>"NCT00001426", "BriefTitle"=>"A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer", "NCTIdAliasList"=>{"NCTIdAlias"=>["NCT00019045"]}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"950055"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-C-0055"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Cyclophosphamide", "InterventionType"=>"Drug"}, {"InterventionName"=>"Paclitaxel", "InterventionType"=>"Drug"}, {"InterventionName"=>"Cisplatin", "InterventionType"=>"Drug"}, {"InterventionName"=>"G-CSF", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Elise C Kohn, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}