Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer

Study Overview
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Brief Summary
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RATIONALE: Sunitinib 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. PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line therapy in treating patients with locally advanced or metastatic transitional cell cancer.

Detailed Description
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OBJECTIVES: Primary To determine the objective tumor response rate according to RECIST criteria in patients with locally advanced or metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate who failed or progressed after first-line chemotherapy . Secondary To determine the safety of this drug. To determine the time to response and duration of response. To determine the progression-free survival and overall survival of these patients. To evaluate the quality of life of these patients. OUTLINE: This is a multicenter study. Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 2 months.

Official Title
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A Multicentre Phase II Trial to Determine the Efficacy of the Anti-Tyrosine Kinase Sunitinib (Sutent®) as Second Line Therapy in Patients With Transitional Cell Carcinoma (TCC) of the Urothelium Which Failed or Progressed After First Line Chemotherapy for Advanced or Metastatic Disease

Conditions
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Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

Intervention / Treatment
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* Drug: sunitinib malate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed transitional cell cancer of the urothelium Advanced or metastatic disease Disease failed or progressed after first-line chemotherapy At least 1 non-irradiated measurable lesion assessed by CT scan or MRI according to RECIST No progressive brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 ANC ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8g/dL Total bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in presence of liver metastases) Creatinine clearance ≥ 40 mL/min PTT and INR ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during study treatment No uncontrolled high BP, defined as > 150/100 mm Hg despite treatment No diagnosis of a second malignancy within the past 5 years, except for basal cell or squamous cell carcinoma of the skin, incidental PT2 prostate cancer found on radical cystoprostatectomy material, or carcinoma in situ of the cervix, that has been adequately treated with no evidence of recurrence in the past 12 months None of the following within the past 12 months: Myocardial infarction Severe/unstable angina pectoris Coronary artery bypass graft Symptomatic congestive heart failure Cerebrovascular accident Transient ischemic attack Pulmonary embolism At least 6 months since deep vein thrombosis No NCI CTCAE grade 3 hemorrhage within the past 4 weeks No pre-existing neuropathy ≥ NCI CTCAE grade 2 No history of interstitial pneumonitis or pulmonary fibrosis No ongoing cardiac arrhythmias ≥ NCI CTCAE grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval (> 450 msec for males or > 470 msec for females) No ongoing active infection No patients deprived of liberty or who are under supervision (including a trusteeship) No psychological, familial, sociological, or geographic condition potentially hampering compliance with study treatment and follow-up Patients must be affiliated to a social security system PRIOR CONCURRENT THERAPY: Prior platinum-based therapy allowed No prior sunitinib malate No prior radiotherapy to ≥ 25% of marrow producing area Prior neoadjuvant or adjuvant chemotherapy allowed More than 2 weeks since prior and no concurrent oral anticoagulant agents at therapeutic doses Low molecular weight heparin allowed At least 30 days since prior chemotherapy or radiotherapy and recovered No other concurrent anticancer treatment, including experimental agents, or participation in another investigational trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sunitinib malate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response as assessed by RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Time to response and duration of response |  |  | 
| Safety |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic transitional cell cancer of the renal pelvis and ureter, 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, recurrent bladder cancer