Metastatic Pancreatic CancerPhase 2NCT00922896
Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Cisplatin, Erlotinib (Tarceva) in people with Metastatic Pancreatic Cancer, run by Gyeongsang National University Hospital at 3 sites in South Korea.
Trial summary
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Gemcitabine, Cisplatin, Erlotinib (Tarceva)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2009to May 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18
- Younger than 75
- ECOG performance status 0 or 1
- Histologically confirmed adenocarcinoma of the pancreas
- Metastatic pancreatic cancer
- No prior chemotherapy for metastatic pancreatic cancer
- A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
Who cannot join
- A patient with no measurable disease
- A patient who received previous palliative chemotherapy for pancreatic cancer
- A patient with locally advanced pancreatic cancer
- A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
- A patient with previous active or passive immunotherapy
- A pregnant or lactating patient
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Dong-A University Hospital
Busan, 602-715
Gyeongsang Unversity Hospital
Jinju
Chung-Ang University Hospital
Seoul, 156-755
About this study
Official title: A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Gemcitabine, Cisplatin, Erlotinib (Tarceva)
- Keywords
- Gemcitabine, Cisplatin, Erlotinib
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, Cisplatin, Erlotinib (Tarceva)Drug
- Erlotinib 100 mg po q d daily AND
- Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8
- Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8
Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| GPE | Experimental | Gemcitabine-Cisplatin-Erlotinib Receives: Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer
Measured: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Pancreatic CancerStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A University Hospital, Chung-Ang University Hospital
- Responsible party
- Principal investigator, Jung Hun Kang, Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922896
- Sponsor's protocol ID
- Gyeongsang-001
- Status last verified
- Nov 2012
- First submitted
- 2 Jun 2009
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hwang IG, Jang JS, Oh SY, Lee S, Kwon HC, Lee GW, Go S, Kang MH, Cha YJ, Kang JH. A phase II trial of Erlotinib in combination with gemcitabine and cisplatin in advanced pancreatic cancer. Invest New Drugs. 2012 Dec;30(6):2371-6. doi: 10.1007/s10637-012-9792-z.
PubMed 22302349
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00922896
- Acronym / sponsor ID
- Gyeongsang-001
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Gemcitabine, Cisplatin, Erlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A University Hospital, Chung-Ang University Hospital
- Study start
- Jun 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Jun 2009 (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.
The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPE | Experimental | Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)Gemcitabine-Cisplatin-Erlotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age older than 18
- Younger than 75
- ECOG performance status 0 or 1
- Histologically confirmed adenocarcinoma of the pancreas
- Metastatic pancreatic cancer
Key exclusion criteria (6 listed)
- A patient with no measurable disease
- A patient who received previous palliative chemotherapy for pancreatic cancer
- A patient with locally advanced pancreatic cancer
- A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
- A patient with previous active or passive immunotherapy
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 |
|---|---|---|
| Gemcitabine, Cisplatin, Erlotinib (Tarceva)* Erlotinib 100 mg po q d daily AND * Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8 * Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8 Every 3 weeks | Drug | GPE |
Primary outcome
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer
Time frame: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
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 20 Nov 2012.
- Derived from this study: PubMed 22302349Hwang IG, Jang JS, Oh SY, Lee S, Kwon HC, Lee GW, Go S, Kang MH, Cha YJ, Kang JH. A phase II trial of Erlotinib in combination with gemcitabine and cisplatin in advanced pancreatic cancer. Invest New Drugs. 2012 Dec;30(6):2371-6. doi: 10.1007/s10637-012-9792-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Cisplatin, Erlotinib (Tarceva) in people with Metastatic Pancreatic Cancer, run by Gyeongsang National University Hospital at 3 sites 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 7 inclusion and 6 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 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer (time frame: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922896, which also lists 1 linked publication.
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 20 Nov 2012.