Pancreatic CancerPhase 2NCT00564720
Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Erlotinib and Oxaliplatin in people with Pancreatic Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
Trial summary
This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine, Erlotinib and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesGreece
- Study dates
- Dec 2006to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed pancreatic cancer.
- Measurable disease.
- Absence of ascites or obstructive jaundice.
- ECOG Performance Status 0-2.
- Adequate liver kidney and bone marrow function.
- Written informed consent.
Who cannot join
- Chronic diarrheic syndrome.
- Uncontrolled brain metastases after radiation.
- Liver infiltration over 50%.
- Peripheral neuropathy ≥ 2.
- No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.
- No active uncontrolled infection.
- Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Women who are pregnant or lactating.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupoli
Air Forces Military Hospital of Athens
Athens
Errikos Ntynan General Hospital
Athens
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Athens
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
Athens
State General Hospital of Larissa
Larissa
Diabalkaniko General Hospital of Thessaloniki
Thessaloniki
About this study
Official title: Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Erlotinib, Oxaliplatin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
GemcitabineDrug
Also called Gemzar
Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
ErlotinibDrug
Also called Tarceva
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GEM/TAR Receives: Drug: Gemcitabine; Drug: Erlotinib |
| 2 | Experimental | GEM/OX/TAR Receives: Drug: Gemcitabine; Drug: Erlotinib; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1 year survival
Secondary outcomes (4)
Progression free interval
Measured: 1 year
Response rate
Measured: Objective responses confirmed by CT or MRI on 3rd and 6th cycle
Toxicity profile
Measured: Toxicity assessment on each chemotherapy cycle
Symptoms improvement
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Due to poor accrual of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Responsible party
- Sponsor
- Investigators
- Vassilis Georgoulias, MD, Principal investigator, University Hospital of Crete, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564720
- Sponsor's protocol ID
- CT/06.13
- Status last verified
- Feb 2013
- First submitted
- 27 Nov 2007
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00564720
- Acronym / sponsor ID
- CT/06.13
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor accrual of the study
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Dec 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Nov 2007 (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 randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Gemcitabine, Drug: ErlotinibGEM/TAR |
| 2 | Experimental | Drug: Gemcitabine, Drug: Erlotinib, Drug: OxaliplatinGEM/OX/TAR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed pancreatic cancer.
- Measurable disease.
- Absence of ascites or obstructive jaundice.
- ECOG Performance Status 0-2.
- Adequate liver kidney and bone marrow function.
Key exclusion criteria (8 listed)
- Chronic diarrheic syndrome.
- Uncontrolled brain metastases after radiation.
- Liver infiltration over 50%.
- Peripheral neuropathy ≥ 2.
- No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.
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 |
|---|---|---|
| GemcitabineAlso: GemzarGemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles | Drug | 1 |
| GemcitabineAlso: GemzarGemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles | Drug | 2 |
| ErlotinibAlso: TarcevaErlotinib 100 mg by mouth (p.o.), daily until disease progression | Drug | 1, 2 |
| OxaliplatinAlso: EloxatinOxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles | Drug | 2 |
Primary outcome
Overall Survival
Time frame: 1 year survival
4 secondary outcomes
Progression free interval
Time frame: 1 year
Response rate
Time frame: Objective responses confirmed by CT or MRI on 3rd and 6th cycle
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Symptoms improvement
Time frame: Assessment every two cycles
Results and safety
The study was stopped early (reason given: Due to poor accrual of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
Vassilis Georgoulias, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
8 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, Erlotinib and Oxaliplatin in people with Pancreatic Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. 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 was stopped early (reason given: Due to poor accrual of the study). Results are not available in the source record.
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?
Overall Survival (time frame: 1 year survival). 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 15 Feb 2013.