{
  "FullStudy":{
    "Rank":217756,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517243",
          "OrgStudyIdInfo":{
            "OrgStudyId":"D1011"
          },
          "Organization":{
            "OrgFullName":"Dartmouth-Hitchcock Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Phase II Study of Alternating Sunitinib and Temsirolimus",
          "OfficialTitle":"Alternating Targeted Therapy in Patients With Metastatic Renal Cell Carcinoma: A Phase II Study of Alternating Sunitinib and Temsirolimus"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2019",
          "OverallStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2020",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 6, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 10, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Lionel.D.Lewis, MD",
            "ResponsiblePartyInvestigatorTitle":"Medical Director of the Dartmouth Clinical Trials Office",
            "ResponsiblePartyInvestigatorAffiliation":"Dartmouth-Hitchcock Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Dartmouth-Hitchcock Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"In the past 5 years, treatment for metastatic Renal Cell Carcinoma (mRCC) has focused on agents directed at blocking tumor and vascular growth pathways. Sunitinib blocks the vascular endothelial growth factor receptor (VEGFr) and temsirolimus is an inhibitor of mammalian target of rapamycin (mTOR). Both sunitinib and temsirolimus are FDA approved agents for mRCC. When agents like these are given together, the toxicity increases but they can be given safely, at full doses, sequentially. We hypothesize that alternating these agents will double the progression free survival (PFS) of the agents when given sequentially.",
          "DetailedDescription":"SUMMARY: Alternating Targeted Therapy in Patients with Metastatic Renal Cell Carcinoma: A Phase II Study of Alternating Sunitinib and Temsirolimus\n\nPatients with measurable metastatic renal cell carcinoma (any histology) are eligible. All patients will be treated as outlined below with sunitinib alternating with temsirolimus.\n\nPatients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease.\n\nA cycle is defined as:\n\nSunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Metastatic Renal Cell Carcinoma"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Metastatic Renal Cell Carcinoma",
              "sunitinib",
              "alternating",
              "temsirolimus"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"37",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Alternating Sunitinib and Temsirolimus",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"A cycle is defined as:\n\nSunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Sunitinib",
                    "Drug: Temsirolimus"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Sunitinib",
                "InterventionDescription":"Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Alternating Sunitinib and Temsirolimus"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Sutent"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Temsirolimus",
                "InterventionDescription":"Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Alternating Sunitinib and Temsirolimus"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "TORISEL®"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Time to Progression",
                "PrimaryOutcomeDescription":"To determine the time to progression in metastatic renal cell carcinoma patients treated with alternating targeted therapy",
                "PrimaryOutcomeTimeFrame":"From the date of randomization until the first documented progression or date of death from any cause."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Clinical Response Rate",
                "SecondaryOutcomeDescription":"To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol.",
                "SecondaryOutcomeTimeFrame":"Every 12 weeks until progression, estimated time frame is 18 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria\n\nHistologically confirmed metastatic renal cell cancer with evaluable disease.\nPatients must be at least 2 weeks from their last immunotherapy, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects.\nKarnofsky Performance Status ≥60%\nLife expectancy ≥ twelve weeks\nAdequate end organ function:\n\nCardiac Left ventricular ejection fraction (LVEF) ≥lower limit of institutional normal (LLN) as assessed by echocardiography (ECHO) . The same modality used at baseline must be applied for subsequent evaluations.\n\nWomen should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study and practicing acceptable forms of birth control\nAppropriate Contraception in both sexes\nThe patient must be competent and signed informed consent.\n\nEXCLUSION CRITERIA\n\nConcomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.\nIn patients with a prior history of invasive malignancy, less than five years in complete remission.\nHave evidence of significant co-morbid illness such as uncontrolled diabetes, hypertension or active infection that would preclude treatment on this regimen.\nPrior treatment with either sunitinib or temsirolimus\nClinically significant gastrointestinal abnormalities\nPresence of uncontrolled infection.\n\nProlongation of corrected QT interval (QTc) > 480 milliseconds - History of any one or more of the following cardiovascular conditions within the past 12 months:\n\nCardiac angioplasty or stenting\nMyocardial infarction\nUnstable angina\nCoronary artery by-pass graft surgery\nSymptomatic peripheral vascular disease\nClass III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)\nHistory of cerebrovascular accident (CVA) including transient ischemic attack (TIA) within the past 12 months.\nHistory of pulmonary embolism or untreated deep venous thrombosis (DVT)within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible.\n\nPoorly controlled hypertension [defined as systolic blood pressure (SBP) of\n\n≥150 or diastolic blood pressure (DBP) of ≥ 90. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.\n\nPrior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.\nEvidence of active bleeding or bleeding diathesis\nHemoptysis within 6 weeks of first dose of study drug.\nKnown endobronchial lesions and/or lesions infiltrating major pulmonary vessels\nAny serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.\nIs now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug any minor surgeries (i.e. skin biopsy, tooth extraction, etc.) and recovered from all ill effects.\nAny ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.\nKnown immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to sunitinib or temsirolimus.\nUntreated brain metastasis. (Brain metastases that are stable based on radiographic evidence 4 weeks after radiation and/or surgery are permitted).",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Lionel D Lewis, MD",
                "OverallOfficialAffiliation":"Dartmouth-Hitchcock Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Dartmouth-Hitchcock Medical Center",
                "LocationCity":"Lebanon",
                "LocationState":"New Hampshire",
                "LocationZip":"03756",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of Vermont, Vermont Cancer Center",
                "LocationCity":"Burlington",
                "LocationState":"Vermont",
                "LocationZip":"05401",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000020123",
                "InterventionMeshTerm":"Sirolimus"
              },{
                "InterventionMeshId":"D000077210",
                "InterventionMeshTerm":"Sunitinib"
              },{
                "InterventionMeshId":"D000068338",
                "InterventionMeshTerm":"Everolimus"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000020533",
                "InterventionAncestorTerm":"Angiogenesis Inhibitors"
              },{
                "InterventionAncestorId":"D000043924",
                "InterventionAncestorTerm":"Angiogenesis Modulating Agents"
              },{
                "InterventionAncestorId":"D000006133",
                "InterventionAncestorTerm":"Growth Substances"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000006131",
                "InterventionAncestorTerm":"Growth Inhibitors"
              },{
                "InterventionAncestorId":"D000047428",
                "InterventionAncestorTerm":"Protein Kinase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000007166",
                "InterventionAncestorTerm":"Immunosuppressive Agents"
              },{
                "InterventionAncestorId":"D000007155",
                "InterventionAncestorTerm":"Immunologic Factors"
              },{
                "InterventionAncestorId":"D000000900",
                "InterventionAncestorTerm":"Anti-Bacterial Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000000903",
                "InterventionAncestorTerm":"Antibiotics, Antineoplastic"
              },{
                "InterventionAncestorId":"D000000935",
                "InterventionAncestorTerm":"Antifungal Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M255",
                "InterventionBrowseLeafName":"Everolimus",
                "InterventionBrowseLeafAsFound":"Temsirolimus",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M1698",
                "InterventionBrowseLeafName":"Sunitinib",
                "InterventionBrowseLeafAsFound":"Sunitinib",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M20544",
                "InterventionBrowseLeafName":"Sirolimus",
                "InterventionBrowseLeafAsFound":"Temsirolimus",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M20902",
                "InterventionBrowseLeafName":"Angiogenesis Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M24407",
                "InterventionBrowseLeafName":"Protein Kinase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8795",
                "InterventionBrowseLeafName":"Immunosuppressive Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8784",
                "InterventionBrowseLeafName":"Immunologic Factors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2803",
                "InterventionBrowseLeafName":"Anti-Bacterial Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2805",
                "InterventionBrowseLeafName":"Antibiotics, Antitubercular",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2835",
                "InterventionBrowseLeafName":"Antifungal Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M4835",
                "InterventionBrowseLeafName":"Clotrimazole",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M10379",
                "InterventionBrowseLeafName":"Miconazole",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000002277",
                "ConditionMeshTerm":"Carcinoma"
              },{
                "ConditionMeshId":"D000002292",
                "ConditionMeshTerm":"Carcinoma, Renal Cell"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009375",
                "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial"
              },{
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000000230",
                "ConditionAncestorTerm":"Adenocarcinoma"
              },{
                "ConditionAncestorId":"D000007680",
                "ConditionAncestorTerm":"Kidney Neoplasms"
              },{
                "ConditionAncestorId":"D000014571",
                "ConditionAncestorTerm":"Urologic Neoplasms"
              },{
                "ConditionAncestorId":"D000014565",
                "ConditionAncestorTerm":"Urogenital Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000007674",
                "ConditionAncestorTerm":"Kidney Diseases"
              },{
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M4116",
                "ConditionBrowseLeafName":"Carcinoma",
                "ConditionBrowseLeafAsFound":"Carcinoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4130",
                "ConditionBrowseLeafName":"Carcinoma, Renal Cell",
                "ConditionBrowseLeafAsFound":"Renal Cell Carcinoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10903",
                "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2166",
                "ConditionBrowseLeafName":"Adenocarcinoma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9286",
                "ConditionBrowseLeafName":"Kidney Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15903",
                "ConditionBrowseLeafName":"Urologic Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15898",
                "ConditionBrowseLeafName":"Urogenital Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4931",
                "ConditionBrowseLeafName":"Renal Cell Carcinoma",
                "ConditionBrowseLeafAsFound":"Renal Cell Carcinoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T1347",
                "ConditionBrowseLeafName":"Clear Cell Renal Cell Carcinoma",
                "ConditionBrowseLeafAsFound":"Renal Cell Carcinoma",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}