Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Urethral Neoplasms; Kidney Neoplasms; Ureteral Neoplasms
Intervention: sunitinib malate
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; anterior urethral cancer; posterior urethral cancer; recurrent urethral cancer; metastatic transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter; urethral cancer associated with invasive bladder cancer

Summary:

      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for their growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
      progressive metastatic transitional cell cancer of the urothelium.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of
             the following sites:

               -  Bladder

               -  Urethra

               -  Ureter

               -  Renal pelvis

          -  Progressive metastatic disease

               -  Progressive disease defined as new or progressive lesions on cross-sectional
                  imaging

               -  Progressed despite prior treatment with cytotoxic chemotherapy

          -  Measurable disease

          -  Previously treated disease, as defined by the following:

               -  Received treatment with 1-4 cytotoxic agents

               -  Prior therapy must have included ≥ 1 of the following:

                    -  Cisplatin

                    -  Carboplatin

                    -  Paclitaxel

                    -  Docetaxel

                    -  Gemcitabine hydrochloride

               -  Prior cytotoxic agents in the perioperative or metastatic setting allowed and may
                  have been administered sequentially (e.g., first-line treatment followed by
                  second-line treatment at time of progression) or all as part of a single regimen

          -  No symptomatic CNS metastases

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 60-100%

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL

          -  Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease is present)

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver function
             abnormalities are due to underlying malignancy)

          -  Creatinine ≤ 2.0 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  None of the following within the past 6 months:

               -  Myocardial infarction

               -  Severe or unstable angina

               -  Coronary or peripheral artery bypass graft

               -  Symptomatic congestive heart failure

               -  Cerebrovascular accident or transient ischemic attack

               -  Pulmonary embolism

          -  No ongoing cardiac dysrhythmias ≥ grade 2

          -  No prolonged QTc interval on baseline ECG

          -  No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite
             optimal medical therapy

          -  No preexisting thyroid abnormality (i.e., thyroid function tests that cannot be
             maintained in the normal range with medication)

          -  No known HIV- or AIDS-related illness or other active infection

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy or chemotherapy

          -  At least 4 weeks since prior major surgery

          -  No other concurrent investigational drugs

          -  No concurrent participation in another clinical trial (supportive care trials or
             non-treatment trials [e.g., quality of life] allowed)

          -  No concurrent therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg once daily for
             thromboembolic prophylaxis allowed)