Cisplatin, Gemcitabine Hydrochloride, and Sorafenib Tosylate in Treating Patients With Transitional Cell Cancer of the Bladder

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill more tumor cells. Giving them before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate works in treating patients with node-negative transitional cell cancer of the bladder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Cisplatin; Fluorodeoxyglucose F18; Gemcitabine; Niacinamide; Sorafenib

Criteria

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