|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01222676 |
|
Date of registration:
|
15/10/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Cisplatin, Gemcitabine Hydrochloride, and Sorafenib Tosylate in Treating Patients With Transitional Cell Cancer of the Bladder
|
|
Scientific title:
|
A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder |
|
Date of first enrolment:
|
October 2010 |
|
Target sample size:
|
45 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01222676 |
|
Study type:
|
Interventional |
|
Study design:
|
Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Contact Person |
|
Address:
|
|
|
Telephone:
|
39-2-2390-2359 |
|
Email:
|
roberto.salvioni@istitutotumori.mi.it |
|
Affiliation:
|
|
|
|
Name:
|
Roberto Salvioni, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Bladder Cancer
|
|
Intervention(s)
|
|
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
|
|
Primary Outcome(s)
|
|
Pathological complete response
[Time Frame: No]
|
|
Secondary Outcome(s)
|
|
Correlation between 18FDG-PET and standard CT results
[Time Frame: No]
|
|
Potential biological correlates of disease response and drug activity in tumor tissue samples before and after therapy
[Time Frame: No]
|
|
Safety and tolerability
[Time Frame: Yes]
|
|
Secondary ID(s)
|
|
CDR0000686602
|
|
EU-21077
|
|
EUDRACT-2010-022653-41
|
|
ITA-MIL-IRCCS-INT-52/10
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|