Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00696696|
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : December 21, 2011
Last Update Posted : June 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Erlotinib Drug: Sorafenib||Phase 2|
Until very recently, additional therapies in pancreatic cancer have targeted either the vascular endothelial growth factor (VEGF) or epidermal growth factor (EGF) pathways, a strategy which has shown variable clinical efficacy. This inconsistency is not surprising, given the knowledge that tumors have a certain level of signal redundancy which may limit the effectiveness of any one single-targeted therapy. The dual blockade of the EGF and VEGF pathways takes aim at two of the most active cascades in tumorigenesis. Preliminarily, a phase II study done in pancreatic cancer with gemcitabine, bevacizumab and erlotinib or cetuximab has shown promising results and will most likely proceed to phase III study for definitive efficacy assessment (Kindler et al, 2006).
In this study, targeted blockade is carried one step further with the inhibition of the signaling cascade downstream of receptor tyrosine kinases at the level of raf. Given the fact that the majority of pancreatic tumors display constitutive activation of the Ras/Raf/MEK/ERK pathway, it is hoped that the addition of sorafenib to gemcitabine and erlotinib will obtain a more complete blockade of the signal transduction cascade responsible for pancreatic tumor growth and progression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||June 2013|
Experimental: Combination GES
Combination of Gemcitabine, Erlotinib, and Sorafenib
1000 mg/m^2, intravenous, Days 1, 8, 15 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.
Other Name: GemzarDrug: Erlotinib
150 mg, taken orally, once a day, Days 1-28 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.
Other Names:Drug: Sorafenib
400 mg, taken orally, twice a day, Days 1-28 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.
- 4-month Progression Free Survival (PFS) Rate [ Time Frame: 4 months ]The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles.
- Objective Response Rate [ Time Frame: up to 1 year ]The response rate is the percentage of the patients who have a complete response or partial response based on RECIST from the start of the treatment. The response is evaluated every 2 cycles by radiologic methods (e.g., computer tomography (CT)).
- Median Overall Survival (mOS) [ Time Frame: up to 2 years ]Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment.
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): NCT00696696
|United States, California|
|Desert Regional Medical Center|
|Palm Springs, California, United States, 92262|
|United States, New York|
|New York, New York, United States, 10016|
|New York University Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Deirdre Cohen, MD||NYU School of Medicine|