Trial Information

Phase II Study of Sunitinib in Metastatic and Pretreated Urothelial Cancer

OBJECTIVES

- PRIMARY To determine the antitumor efficacy ( response rate) of sunitinib

- SECONDARY To determine: safety, duration of response, Quality of life (QoL),
progression free survival (PFS) and overall survival (OS).

PLAN OF TREATMENT Patients received sunitinib at a starting dose of 50 mg per day in
repeated 6-week cycles for 4 consecutive weeks followed by 2 weeks off treatment.

Sunitinib was self-administered orally once daily without regard to meals. Dose reduction
for toxicity was allowed to 37.5 until 25 mg/day depending on the type and severity of
toxicity encountered.

Sunitinib treatment was continued until disease progression, unacceptable toxicity or
withdrawal of consent.

EVALUATION

Baseline evaluations included:

- medical history

- physical examination;

- tumor assessment (total body TC and bone scan )

- assessment of ECOG PS

- QoL assessment

- Assessment of left ventricular ejection fraction by echocardiography

- ECG

- Laboratory measurements. Assessment of efficacy and safety

- Evaluation according RECIST criteria every 2 cycles (12 weeks) with TC

- Safety according NCI version 3 every cycle

- QoL every cycle EORTC-QOL-C30.• RESOURCE UTILIZATION ASSESSMENTS

EORTC QLQ-C30 questionnaire, developed by the EORTC for the measurement of quality of life
in cancer patients in clinical trials.

For the analysis, the raw scores of the questionnaire are transformed into a 100-point
scale. For the functional scales, the computed scores range from 0 to 100, with the higher
scores representing a higher level of functioning. For the item scales relative to physical
symptoms and financial impact, higher scores represent a higher level of symptoms or
problems .

STATISTICAL METHODS

Benefit anticipated (%): >30% of response rate. Test size: 5%. Power 80%. Sample size: 25
patients.