Sorafenib in Treating Patients With Advanced or Metastatic Cancer of the Urinary Tract
Condition: Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Bladder Cancer; Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Regional Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage III Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms; Recurrence
Intervention: sorafenib tosylate; laboratory biomarker analysis
Intervention description: Given orally 400mg orally twice daily; Correlative studies
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sorafenib works in treating patients with advanced
      or metastatic cancer of the urinary tract. Sorafenib may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed transitional cell cancer
             of the bladder, renal pelvis or ureter

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral CT scan

          -  Patients must not have had any prior systemic therapy for advanced or metastatic
             disease; prior adjuvant or neoadjuvant chemotherapy is permitted providing it was
             completed at least 4 weeks prior to study entry; radiation therapy is permitted if
             completed > 4 weeks prior to trial entry

          -  Life expectancy of greater than 3 months

          -  ECOG performance status 0 or 1 (Karnofsky >= 70%)

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

          -  Creatinine < 1.5 x ULN OR creatinine clearance >= 45 mL/min/1.73 m^2

          -  No serious medical conditions such as myocardial infarction within 6 months prior to
             entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable
             ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders,
             serious infections, active peptic ulcer disease, or any other medical conditions that
             might be aggravated by treatment

          -  Patients must have tumor lesions accessible for biopsy for correlative studies and
             must be willing to undergo tumor biopsy once before and once during experimental
             therapy; if there is a medical contraindication to biopsy, exception may be granted
             upon discussion with the Principal Investigator/Chair

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Able to swallow and retain oral medication

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Prior systemic therapy for advanced or metastatic urothelial carcinoma

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents

          -  Patients receiving any other investigational agents, or concurrent anticancer therapy

          -  Patients with only non-measurable disease, defined as all other lesions, including
             small lesions (longest diameter < 20mm with conventional techniques or < 10 mm with
             spiral CT scan) and truly non-measurable lesions, which include the following:

               -  Bone lesions

               -  Leptomeningeal disease

               -  Ascites

               -  Pleural/pericardial effusion

               -  Inflammatory breast disease

               -  Lymphangitis cutis/pulmonis

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound evaluation of neurologic and other adverse events

          -  Patients with a history of other active malignancy in the past 5 years (with the
             exception of adequately treated cervical carcinoma in situ and non melanomatous skin
             cancers) are excluded

          -  Uncontrolled intercurrent illness including, but no limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Patients must not have any evidence of a bleeding diathesis

          -  Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation (ie.
             Low dose warfarin) of venous or arterial access devices is allowed provided that the
             requirements for PT, INR or PTT are met

          -  Patients must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs
             (phenytoin, carbamazepine, or Phenobarbital), rifampin or St. John's Wort

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with BAY 43-9006

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to BAY 43-9006

          -  Patients with GI tract disease resulting in an inability to take oral medication,
             malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures
             affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative
             colitis)