Nctid:
NCT00001569
Payload:
{"FullStudy"=>{"Rank"=>474123, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002277", "ConditionMeshTerm"=>"Carcinoma"}, {"ConditionMeshId"=>"D000010534", "ConditionMeshTerm"=>"Peritoneal Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009375", "ConditionAncestorTerm"=>"Neoplasms, Glandular and Epithelial"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000000008", "ConditionAncestorTerm"=>"Abdominal Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000004067", "ConditionAncestorTerm"=>"Digestive System Neoplasms"}, {"ConditionAncestorId"=>"D000004066", "ConditionAncestorTerm"=>"Digestive System Diseases"}, {"ConditionAncestorId"=>"D000010532", "ConditionAncestorTerm"=>"Peritoneal Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M5224", "ConditionBrowseLeafName"=>"Carcinoma", "ConditionBrowseLeafAsFound"=>"Carcinomatosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3275", "ConditionBrowseLeafName"=>"Adenocarcinoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13133", "ConditionBrowseLeafName"=>"Peritoneal Neoplasms", "ConditionBrowseLeafAsFound"=>"Peritoneal Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M2455", "ConditionBrowseLeafName"=>"Hyperthermia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8154", "ConditionBrowseLeafName"=>"Fever", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12010", "ConditionBrowseLeafName"=>"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12005", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7", "ConditionBrowseLeafName"=>"Abdominal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8576", "ConditionBrowseLeafName"=>"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6946", "ConditionBrowseLeafName"=>"Digestive System Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8573", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6945", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13131", "ConditionBrowseLeafName"=>"Peritoneal Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Digestive System Diseases", "ConditionBrowseBranchAbbrev"=>"BC06"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Wounds and Injuries", "ConditionBrowseBranchAbbrev"=>"BC26"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000017239", "InterventionMeshTerm"=>"Paclitaxel"}, {"InterventionMeshId"=>"D000002945", "InterventionMeshTerm"=>"Cisplatin"}]}, "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"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M19227", "InterventionBrowseLeafName"=>"Paclitaxel", "InterventionBrowseLeafAsFound"=>"Based", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5872", "InterventionBrowseLeafName"=>"Cisplatin", "InterventionBrowseLeafAsFound"=>"High", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M8290", "InterventionBrowseLeafName"=>"Fluorouracil", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M231", "InterventionBrowseLeafName"=>"Albumin-Bound Paclitaxel", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25887", "InterventionBrowseLeafName"=>"Tubulin Modulators", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25886", "InterventionBrowseLeafName"=>"Antimitotic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"74"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"January 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2002", "CompletionDateStruct"=>{"CompletionDate"=>"December 2002"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Gastrointestinal", "Adenocarcinoma", "Taxol"]}, "ConditionList"=>{"Condition"=>["Carcinoma", "Peritoneal Neoplasm"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"3133994", "ReferenceType"=>"background", "ReferenceCitation"=>"Fujimoto S, Shrestha RD, Kokubun M, Ohta M, Takahashi M, Kobayashi K, Kiuchi S, Okui K, Miyoshi T, Arimizu N, et al. Intraperitoneal hyperthermic perfusion combined with surgery effective for gastric cancer patients with peritoneal seeding. Ann Surg. 1988 Jul;208(1):36-41. doi: 10.1097/00000658-198807000-00005."}, {"ReferencePMID"=>"3898450", "ReferenceType"=>"background", "ReferenceCitation"=>"Sugarbaker PH, Gianola FJ, Speyer JC, Wesley R, Barofsky I, Meyers CE. Prospective, randomized trial of intravenous versus intraperitoneal 5-fluorouracil in patients with advanced primary colon or rectal cancer. Surgery. 1985 Sep;98(3):414-22."}, {"ReferencePMID"=>"626987", "ReferenceType"=>"background", "ReferenceCitation"=>"Dedrick RL, Myers CE, Bungay PM, DeVita VT Jr. Pharmacokinetic rationale for peritoneal drug administration in the treatment of ovarian cancer. Cancer Treat Rep. 1978 Jan;62(1):1-11."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Two days prior to planned surgery, paclitaxel is infused IV over 24 hours.\n\nPatients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary with each patient, including a spectrum of possible procedures, such as splenectomy, liver resection, pancreatic resection or bowel resection.\n\nAfter cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall. Perfusion rate of cisplatin is 1.5 L/min and the duration is 90 min.\n\nPostoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery.\n\nDose escalation will proceed after patients at a given dose level receive 3 courses. In order to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose escalation. MTD is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6 patients experience hematologic DLT.\n\nTwo to 4 months after surgery, laparotomy will be conducted to determine response to treatment. If tumor size is decreased, patients will undergo a second treatment course identical to the same techniques and chemotherapy agents.", "DetailedDescription"=>"Peritoneal carcinomatosis is considered a terminal stage of tumor progression. Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of this disease. This study will define the maximum tolerated dose of paclitaxel and 5-fluorouracil (5-FU) given as an early post-operative intraperitoneal (IP) dwell therapy after cytoreductive surgery and continuous hyperthermic peritoneal perfusion with cisplatin (CHPP)."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"The patients must have an ECOG performance status of 0 or 1 and have no concomitant medical problems that would place them at increased risk for a major surgical procedure (EG, cardiac or pulmonary disabilities).\n\nPatients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age greater than 65, history of hypertension, first degree relative with atherosclerotic coronary artery disease) will undergo cardiac evaluation and performed which will include an attempt to remove all disease greater than 0.5 cm in diameter."}, "IdentificationModule"=>{"NCTId"=>"NCT00001569", "BriefTitle"=>"Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970072"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-C-0072"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Cisplatin", "InterventionType"=>"Drug"}, {"InterventionName"=>"Paclitaxel", "InterventionType"=>"Drug"}, {"InterventionName"=>"5-FU", "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"}}}}}}
