SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy.

The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC

The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC

• Urothelial Cancer
• Bladder Cancer
• Adult

• Drug: SU011248
  50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
  Other Name: Sutent, Sunitinib
• Drug: Placebo
  50 mg capsule OD PO for 28 days then 14 days rest until disease progression

• Active Comparator: Arm 1
  SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
  Intervention: Drug: SU011248
• Placebo Comparator: Arm 2
  1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment.
  Intervention: Drug: Placebo

Inclusion Criteria:

• Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
• Mixed histology with predominant TCC allowed.
• Failed, intolerant or ineligible for cisplatin based chemo
• Measurable Disease (RECIST)Not previously irradiated.
• Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
• No weight loss >/- 10% within 28 days of day 0
• Adequate Organ Function

Exclusion Criteria:

• Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma.
• Small cell histology
• More than one previous systemic chemo
• Excised metastases without remaining measureable disease
• Prior therapy with angiogenesis inhibitors