Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

November 30, 2011

Study Completion Date

November 30, 2011

Conditions
Bladder CancerURINARY BLADDER
Interventions
DRUG

gemcitabine and cisplatin plus sorafenib

Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months. The total chemotherapy dose for gemcitabine and cisplatin (GC) may be modified for patients with severe obesity (e.g. body surface area (BSA) \> 2.1), after consultation with the Principal Investigator.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00714948 - Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma | Biotech Hunter | Biotech Hunter