S-1, Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01693419|
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Neoplasms||Drug: GES (Gemcitabine, Erlotinib, S-1)||Phase 2|
Pancreatic ductal adenocarcinoma, also known as pancreatic cancer, is an eighth cause of cancer-related deaths in the world. The estimated worldwide incidence of pancreatic cancer was 277,000 cases and an estimated 266,000 patients died from the disease in 20081.
Pancreatic cancer is more common in elderly persons than in younger persons, and characterised by early locoregional spread and distant metastasis. As a result, less than 20% of patients are diagnosed with localized, potentially curable disease, and the median survival is no longer than 3-4 months without effective treatment2.
Single-agent chemotherapy with gemcitabine was considered as standard of care for patients with advanced pancreatic cancer, since Burris et al. demonstrated superiority of gemcitabine over 5-fluorouracil (5-FU) in respect of a survival benefit as well as an improvement in disease related symptoms in a randomized study3.
Nevertheless, the activity of gemcitabine monotherapy in pancreatic cancer was modest, and there was a clear need to improve its efficacy by combining it with other anticancer drugs.
Multiple agents such as 5-FU4, capecitabine5,6, cisplatin7,8, oxaliplatin9, pemetrexed10, irinotecan11, cetuximab12, and bevacizumab13, in combination with gemcitabine have been tested in clinical trials, however, they have failed to improve the outcome.
The only agent that, in combination with gemcitabine, has shown a small, but statistically significant improvement, with a hazard ratio (HR) of 0.82, the absolute improvement in median overall survival (OS) of 5.9 months with gemcitabine versus 6.2 months with the combination, is erlotinib, a small-molecule inhibitor of the epidermal growth factor receptor (EGFR)14. Considering the modest improvement in survival by adding erlotinib to gemcitabine, new combination therapy that have a great impact is urgently needed.
S-1 is an oral fluoropyrimidine derivative that combines tegafur (FT) with two modulators; 5-chloro-2, 4-dihydroxypyridine (CDHP) and oteracil potassium (Oxo) in a 1:0.4:1 molar concentration ratio. The phase II trials of a combination of gemcitabine and S-1 have demonstrated objective response rates of 32-48% and median survival of 8-12 months 15-17.
Therefore, we will conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression, KRAS mutation, and BRAF mutation as predictive or prognostic markers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of S-1 in Combination With Gemcitabine and Erlotinib in Patients With Advanced or Metastatic Pancreatic Cancer|
|Study Start Date :||August 2011|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
Experimental: GES (Gemcitabine, Erlotinib, S-1)
Treatment will be delivered as a 3-week cycle.
Drug: GES (Gemcitabine, Erlotinib, S-1)
Treatment will be delivered as a 3-week cycle.
- Objective response rate [ Time Frame: 1.5 years ]Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.
- Progression free survival [ Time Frame: 1.5 years ]Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause
- Overall survival [ Time Frame: 1.5 years ]Overall survival time will be measured from the start of study treatment until death due to any cause
- Disease control rate [ Time Frame: 1.5 years ]Disease control rate will be measured from the rate of complete response (disappearance of disease), partial response (decrease at least 30% in the sum of the longest diameters of target lesions), and stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) by RECIST (response evaluation criteria in solid tumors) guidelines.
- Toxicity profiles [ Time Frame: 1.5 years ]Adverse events will be descripted and graded using NCI-CTCAE version 4.0
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): NCT01693419
|Korea, Republic of|
|Hallym University Medical Center|
|Anyang, Korea, Republic of|
|Principal Investigator:||Dae Young Zang, DM, PhD||Hallym University Medical Center|