A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder
18 Years
N/A
Both
Bladder Cancer
Trial Information
A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder
OBJECTIVES:
Primary
- To evaluate the activity (pathological complete response) of neoadjuvant cisplatin and
gemcitabine hydrochloride in combination with sorafenib tosylate in patients with
muscle-invasive, node-negative transitional cell carcinoma of the bladder.
Secondary
- To evaluate the safety and tolerability of this regimen in these patients.
- To determine the potential biological correlates of disease response and drug activity
in tumor tissue samples before and after treatment.
- To evaluate the correlation between fludeoxyglucose F 18 positron emission tomography
(18FDG-PET) and standard computed tomography (CT) results and the ability of changes of
18FDG-PET (as measured by EORTC criteria for response) to predict subsequent favorable
response to treatment (pathological complete response rate and progression-free
survival).
OUTLINE: Patients receive cisplatin IV over 20-30 minutes on day 1 and gemcitabine
hydrochloride IV over 30 minutes on days 1 and 8. Patients also receive sorafenib tosylate
twice daily on days 1-21. starting on day 1and continuing up to Treatment repeats every 21
days for 2 courses. Patients are reassessed after course 2, those who experience disease
progression or deemed unresectable are off study. Other patients continue the treatment for
2 more courses*.
NOTE: *Sorafenib tosylate are stopped 14 days prior to planned cystectomy.
No more than 30 days after completion of neoadjuvant therapy, patients undergo planned
radical cystectomy with pelvic lymph-node dissection off study.
Tumor tissue and serum samples may be collected during study for additional biological
studies.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological complete response
Safety Issue:
No
Principal Investigator
Roberto Salvioni, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Authority:
Unspecified
Study ID:
CDR0000686602
NCT ID:
NCT01222676
Start Date:
October 2010
Completion Date:
Related Keywords:
- Bladder Cancer
- transitional cell carcinoma of the bladder
- stage II bladder cancer
- stage III bladder cancer
- stage IV bladder cancer
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
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