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A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder

Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder



- 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.


- 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

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

Inclusion Criteria


- 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


- 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

- 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


- 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:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response

Safety Issue:


Principal Investigator

Roberto Salvioni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano



Study ID:




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