Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer|
- Response Rate by RECIST Criteria. [ Time Frame: Follow-up was approximately 9 weeks ] [ Designated as safety issue: No ]
- Response rate = complete response + partial response per RECIST
- Complete response - disappearance of all target and non-target lesions.
- Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter
- Progression-free Survival (PFS) [ Time Frame: Follow-up was approximately 9 weeks ] [ Designated as safety issue: No ]
- PFS is defined as the duration of time from start of treatment to time to progression.
- Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
- Median Survival [ Time Frame: Length of follow-up was 35 weeks ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm 1 (gemcitabine & pazopanib)
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
Other Name: GemzarDrug: Pazopanib
Other Name: Votrient
To determine the response rate by RECIST criteria.
To determine the progression free survival.
To determine the median survival and overall survival at one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080248
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Joel Picus, M.D.||Washington University School of Medicine|