Pancreas NeoplasmsPhase 2NCT01693419
S-1, Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
A Phase 2 study testing GES (Gemcitabine, Erlotinib, S-1) in people with Pancreas Neoplasms, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
This study 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasms
- What is being tested?
- GES (Gemcitabine, Erlotinib, S-1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed locally advanced unresectable, recurrent or metastatic adenocarcinoma of pancreas (Stage III-IV ; TNM staging system)
- Measurable or evaluable disease by RECIST criteria 1.1
- Minimum age of 18 years
- ECOG Performance status 0-1
- Prior adjuvant chemotherapy without gemcitabine, erlotinib or S-1 is allowed if more than 4 weeks elapsed since completion of chemotherapy.
- More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)
- Adequate organ functions
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
Who cannot join
- Patients treated previously with gemcitabine, erlotinib, or S-1 as adjuvant chemotherapy.
- Patients with CNS metastases
- Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
- Known history of cerebral or leptomeningeal metastases or neurologic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of S-1 in Combination With Gemcitabine and Erlotinib in Patients With Advanced or Metastatic Pancreatic Cancer
This study 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
Read the detailed description
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.
- Conditions
- Pancreas Neoplasms
- Being tested
- GES (Gemcitabine, Erlotinib, S-1)
- Keywords
- pancreas neoplasm, gemcitabine, erlotinib, S-1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GES (Gemcitabine, Erlotinib, S-1)Drug
Also called Gemzar, Tarceva, TS-1
Treatment will be delivered as a 3-week cycle.
- Gemcitabine 1000 mg/m² IV on day 1, 8
- Erlotinib 100 mg/day PO on day 1
- S-1 60 mg/m²/day PO on day 1-14
| Study group | Role | What they receive |
|---|---|---|
| GES (Gemcitabine, Erlotinib, S-1) | Experimental | Treatment will be delivered as a 3-week cycle.
1. Gemcitabine 1000 mg/m² IV on day 1, 8
2. Erlotinib 100 mg/day PO on day 1
3. S-1 60 mg/m²/day PO on day 1-14 Receives: Drug: GES (Gemcitabine, Erlotinib, S-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
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.
Measured: 1.5 years
Secondary outcomes (4)
Progression free survival
Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause
Measured: 1.5 years
Overall survival
Overall survival time will be measured from the start of study treatment until death due to any cause
Measured: 1.5 years
Disease control rate
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.
Measured: 1.5 years
Toxicity profiles
Adverse events will be descripted and graded using NCI-CTCAE version 4.0
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Dae Young Zang, DM, PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693419
- Sponsor's protocol ID
- HMC-HO-GI-1201
- Status last verified
- Aug 2017
- First submitted
- 20 Sep 2012
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of S-1 in Combination With Gemcitabine and Erlotinib in Patients With Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01693419
- Acronym / sponsor ID
- HMC-HO-GI-1201
- Conditions
- Pancreas Neoplasms
- Keywords
- pancreas neoplasm, gemcitabine, erlotinib, S-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Study start
- Aug 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study 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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GES (Gemcitabine, Erlotinib, S-1) | Experimental | Drug: GES (Gemcitabine, Erlotinib, S-1)Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m² IV on day 1, 8 2. Erlotinib 100 mg/day PO on day 1 3. S-1 60 mg/m²/day PO on day 1-14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed locally advanced unresectable, recurrent or metastatic adenocarcinoma of pancreas (Stage III-IV ; TNM staging system)
- Measurable or evaluable disease by RECIST criteria 1.1
- Minimum age of 18 years
- ECOG Performance status 0-1
- Prior adjuvant chemotherapy without gemcitabine, erlotinib or S-1 is allowed if more than 4 weeks elapsed since completion of chemotherapy.
Key exclusion criteria (5 listed)
- Patients treated previously with gemcitabine, erlotinib, or S-1 as adjuvant chemotherapy.
- Patients with CNS metastases
- Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
- Known history of cerebral or leptomeningeal metastases or neurologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GES (Gemcitabine, Erlotinib, S-1)Also: Gemzar, Tarceva, TS-1Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m² IV on day 1, 8 2. Erlotinib 100 mg/day PO on day 1 3. S-1 60 mg/m²/day PO on day 1-14 | Drug | GES (Gemcitabine, Erlotinib, S-1) |
Primary outcome
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.
4 secondary outcomes
Progression free survival
Time frame: 1.5 years
Overall survival
Time frame: 1.5 years
Disease control rate
Time frame: 1.5 years
Toxicity profiles
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Young Zang, DM, PhD principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GES (Gemcitabine, Erlotinib, S-1) in people with Pancreas Neoplasms, run by Hallym University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.