Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Stage IV Pancreatic Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer|
- Overall Survival Rate at 6 Months [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.
- Overall Response Rate [ Time Frame: Evaluated at end of every second 3 week cycle for response ] [ Designated as safety issue: No ]Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.
|Study Start Date:||December 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Given IVDrug: carboplatin
Given IVOther: laboratory biomarker analysis
I. To evaluate overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic cancer.
I. To evaluate the objective tumor response rate, the duration of response, time to tumor progression, and overall survival.
II. To evaluate biological effects on peripheral blood mononuclear cells. III. To evaluate the safety profile of this combination. IV. To evaluate archival tissue for epithelial-to-mesenchymal transition (EMT) and E-cadherin and Zeb-1.
Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11 and carboplatin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416793
|United States, Texas|
|MD Anderson Cancer Network|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gauri Varadhachary||MD Anderson Cancer Network|