Gemzar, Cisp, Sunitinib Urothelial Ca
|ClinicalTrials.gov Identifier: NCT00821327|
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : March 2, 2016
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Cancer||Drug: Gemcitabine, Cisplatin, Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Study Arm
Gemcitabine, Cisplatin, Sunitinib
Drug: Gemcitabine, Cisplatin, Sunitinib
Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
Other Name: Gemzar, Sutent
- Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib. [ Time Frame: 2 years ]Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
- Progression-free Survival [ Time Frame: 2 years ]
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
- Ovarall Survival (OS) [ Time Frame: 2 years ]OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821327
|Principal Investigator:||Guru Sonpavde, MD||US Oncology|
|Principal Investigator:||Thomas E Hutson, DO||US Oncology|