Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas
|ClinicalTrials.gov Identifier: NCT01783054|
Recruitment Status : Terminated (Study terminated due to low accrual)
First Posted : February 4, 2013
Results First Posted : November 9, 2015
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma Pancreas||Procedure: Surgery Genetic: Genetic Expression Drug: Chemotherapy||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2015|
Experimental: chemotherapy, surgery, genetic expression
All patients enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Treatment will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks.
Patients will move on to surgery, 4-8 weeks after chemotherapy treatment. Patients must be recovered from any adverse effects of the chemotherapy before proceeding with surgery.
As part of this study, tissue samples will be collect from each patient at the time of surgery for gene expression testing
Subjects will then receive surgery at MUSC within 4-8 weeks following completion of chemotherapy
Genetic: Genetic Expression
Subjects will have genetic expression testing done on their tissue samples.
Patients will receive gemcitabine at 1000 mg/m2 and abraxane at 125 mg/m2 intravenously on days 1, 8 and 15 of a 28 day cycle for 2 cycles
- Tumor Response [ Time Frame: at time of surgery ]Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen. A good response is defined as a grade III or IV histopathologic appearance, equivalent to <10% viable tumor.
- Number of Participants With R0 Resection Status. [ Time Frame: at time of surgery ]R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor.
- Estimate Median Time to Recurrence. [ Time Frame: 2 years ]Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.
- Estimate Median Overall Survival [ Time Frame: 2 years ]Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.
- Number of Adverse Events Reported in Subjects Enrolled. [ Time Frame: First study drug administration until end of study ]Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0.
- Circulating Tumor Cells (CTC) [ Time Frame: From enrollment to surgery ]To evaluate and describe CTC number, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniquen from patients with pancreatic adenocarcinoma. To determine and evaluate the correlation between expression of biomarkers in CTCs and expression of biomarkers in resected tissue specimen with the same cancer patient.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783054
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Eric Kimchi, MD||Medical University of South Carolina|