Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer

• Status: Unknown status
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity.

Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy.

No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority.

Several drugs have been used in second line for metastatic disease with poor results.

The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine).

No previous studies have been published with sunitinib in metastatic bladder cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Campania Younger Oncologists Association
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• cytological confirmation of UROTHELIAL carcinoma

• Failure of Cisplatin-gemcitabine regimen as first-line

• Presence of measurable metastases

• Performance status 0-1 ECOG

• Age of 18 years or older

• Written informed consent

• Adequate organ function ( based on tests of hematologic, hepatic, renal and cardiac function).

Exclusion Criteria:

• administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)

• brain metastases

• significant cardiac events within the 6 months prior to study drug administration.