Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01195415|
Recruitment Status : Completed
First Posted : September 6, 2010
Results First Posted : October 7, 2015
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Pancreatic Carcinoma Stage IV Pancreatic Cancer||Drug: Gemcitabine Hydrochloride Other: Laboratory Biomarker Analysis Drug: Vismodegib||Phase 2|
I. To obtain tumor biopsies before and after therapy with GDC-0449 (vismodegib) to evaluate the effect of inhibition of hedgehog signaling on pancreatic cancer stem cells by: evaluating the tumor for number and percentage of pancreatic cancer stem cells before and after treatment with GDC-0449.
I. To assess progression free survival (PFS) at 3 months following treatment with GDC-0449 and gemcitabine (gemcitabine hydrochloride).
II. To assess response rate to treatment and overall survival in patients with advanced pancreas cancer treated with GDC-0449 alone and in combination with gemcitabine.
III. To evaluate the toxicity of GDC-0449 alone and in combination with gemcitabine.
Patients receive vismodegib orally (PO) once daily (QD) on days 1-28 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cancer Stem Cells and Inhibition of Hedgehog Pathway Signaling in Advanced Pancreas Cancer: A Pilot Study of GDC-0449 in Combination With Gemcitabine|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||October 10, 2014|
Experimental: Treatment (vismodegib, gemcitabine hydrochloride)
Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
- Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS [ Time Frame: 3 weeks ]The median percentage of CD44+CD24+ESA+ cells from needle biopsy were calculated at baseline and at 3 weeks using FACS. The difference between the two time points was calculated.
- The Number of Participants With an Objective Best Response (CR + PR) [ Time Frame: Up to 4 weeks ]The number of participants with either a complete response (CR) or a partial response (PR) will be calculated. A CR is defined as the disappearance of all target lesions. A PR is defined as at least a 30% decrease in the sum of the diameters of target lesions.
- Median Progression Free Survival [ Time Frame: Up to 24 months ]Median progression free survival was calculated for all treated patients. Assessed using the Kaplan-Meier method. The 95% confidence interval for this estimate will be computed using the Greenwood's formula.
- Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0 [ Time Frame: Up to 4 weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT01195415
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mark Zalupski||University of Michigan Rogel Cancer Center|