Clinical trial NCT00714948 (phase 2, status: terminated)
Conditions: bladder cancer, urinary bladder
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4, Q64.10, Q64.11, Q64.12, Q64.19
Drugs: gemcitabine and cisplatin plus sorafenib
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    lack of accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have measurable or evaluable urothelial cancer.

               -  Measurable disease includes unresectable or metastatic urothelial tract tumors
                  that are unidimensionally measurable by xray,CT/MRI scan or physical examination.

               -  Evaluable disease is restricted to patients with unresectable primary bladder
                  tumors which can be evaluated for response by cystoscopy.

          -  Pathologic confirmation by the Department of Pathology at MSKCC.

          -  Karnofsky Performance Status (KPS) ≥60%.

          -  Adequate marrow function defined as granulocytes ≥ 1500 cells/mm 3 , platelets ≥
             100,000 cells/mm 3 , and hemoglobin ≥ 8.0 g/dl.

          -  Serum creatinine < 2.0 mg/dl

          -  24-hour urine sample demonstrating creatinine clearance ≥ 60 ml/min/1.73m2 or
             calculated creatinine clearance ≥ 60 ml/min/1.73m 2 using the formula: Jeliffe
             Equation: estimated creatinine clearance = 98 x (0.8 [age(yrs) 20]/Serum Creatinine
             (mg/dL) x (0.9 if Female))

          -  Adequate hepatic function defined as:

               -  Total Bilirubin < or = to 1.5 x ULN

               -  AST and ALT < or = to 3.0 x ULN (< or = to 5.0 x ULN is acceptable if liver has
                  tumor involvement)

          -  Normal coagulation profile including PT/INR and PTT, unless patient is receiving
             anticoagulation therapy with agents such as warfarin or heparin.

          -  Age ≥ 18 years

          -  Informed consent

          -  Women of childbearing potential must have a negative pregnancy test.

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter.

          -  Patients are encouraged to continue barrier method contraception for two years or
             longer after treatment.

        Exclusion Criteria:

          -  Prior treatment with systemic chemotherapy (prior intravesical therapy is permitted).

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study.

          -  Blood Pressure of > 150/100 mm Hg.

          -  Irradiation within 4 weeks of start of protocol.

          -  Evidence of another active cancer, except for nonmelanoma skin carcinoma, insitu
             carcinoma of the cervix curatively treated, and adenocarcinoma of the prostate that
             has been surgically treated with a post-treatment PSA that is nondetectable.

          -  Significant cardiovascular disease including congestive heart failure (New York Heart
             Association Class II or higher) or active angina pectoris.

          -  History of a myocardial infarction within 6 months.

          -  History of a stroke or transient ischemic attack within 6 months.

          -  Clinically significant peripheral vascular disease.

          -  Evidence of bleeding diathesis or coagulopathy.

          -  Presence of central nervous system or brain metastases.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0.

          -  Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to Day 0.

          -  History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
             within 6 months prior to Day 0.

          -  Serious nonhealing wound, ulcer, or bone fracture.

          -  History of persistent gross hematuria.

          -  Uncontrolled infection.

          -  Hypersensitivity to sorafenib, or any component of the formulation.

          -  Pregnant (positive pregnancy test) or lactating.

          -  Inability to comply with the study and/or followup procedures.