The purpose of this study is to find out if using the combination of standard chemotherapy (gemcitabine and cisplatin) plus this new targeted pill (sunitinib) can help shrink your tumor before you undergo surgery for your bladder cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period.
Gemcitabine 1,000 mg/m\^2
cisplatin 35 mg/m\^2 will be administered intravenously on days 1 and 8.
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States
The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Time frame: 2 years
The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
is defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Time frame: 2 years
The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.
The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.
Time frame: 2 years
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Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States