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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01222676
Recruitment Status : Unknown
Verified October 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 18, 2010
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Drug: sorafenib tosylate Other: imaging biomarker analysis Other: laboratory biomarker analysis Procedure: computed tomography Procedure: neoadjuvant therapy Radiation: fludeoxyglucose F 18 Phase 2

Detailed Description:



  • 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder
Study Start Date : October 2010
Estimated Primary Completion Date : October 2013

Primary Outcome Measures :
  1. Pathological complete response

Secondary Outcome Measures :
  1. Safety and tolerability
  2. Potential biological correlates of disease response and drug activity in tumor tissue samples before and after therapy
  3. Correlation between 18FDG-PET and standard CT results

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01222676

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Fondazione Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Contact Person    39-2-2390-2359   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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Principal Investigator: Roberto Salvioni, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01222676    
Other Study ID Numbers: ITA-MIL-IRCCS-INT-52/10
CDR0000686602 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: October 2010
Keywords provided by National Cancer Institute (NCI):
transitional cell carcinoma of the bladder
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Fluorodeoxyglucose F18
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors