Status:
UNKNOWN
Cisplatin, Gemcitabine Hydrochloride, and Sorafenib Tosylate in Treating Patients With Transitional Cell Cancer of the Bladder
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from d...
Detailed Description
OBJECTIVES: Primary * To evaluate the activity (pathological complete response) of neoadjuvant cisplatin and gemcitabine hydrochloride in combination with sorafenib tosylate in patients with muscle-...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed transitional cell carcinoma (TCC) of the bladder at the time of diagnostic transurethral resection of the bladder tumor (TURB)\*
- Muscle-invasive (T ≥ 2) disease at TURB OR clinical stage T3 or T4 disease (e.g., T2 patients will not be eligible without a histological documentation of invasive disease)
- NOTE: \*Confirmation of TCC histology based on pathologic review at Fondazione Istituto Nazionale dei Tumori Milan will be required in all cases.
- Clinically node-negative (cN0) disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 2,000/µL
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Serum creatinine ≤ 1.5 mg/dL
- AST/ALT \< 2.5 times upper limit of normal (ULN) (\< 5 times ULN if due to hepatic metastases)
- Total bilirubin \< 1.5 times ULN
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Negative serology for the following infectious diseases:
- HIV type 1 or 2
- Hepatitis B surface antigen (active carriers)
- Hepatitis C
- PRIOR CONCURRENT THERAPY:
- No prior systemic therapies except for intravesical therapy for superficial disease
- No prior sorafenib tosylate
- No prior systemic chemotherapy
- At least 4 weeks since prior investigational agents
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01222676
Start Date
October 1 2010
Last Update
August 12 2013
Active Locations (1)
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1
Fondazione Istituto Nazionale dei Tumori
Milan, Italy, 20133