Pancreatic CancerPhase 1/2NCT01042028
A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
A Phase 1/2 study testing Everolimus, Cetuximab, Irinotecan and Capecitabine, Oxaliplatine in people with Pancreatic Cancer, run by Per Pfeiffer at 2 sites in Denmark.
Trial summary
This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Everolimus, Cetuximab, Irinotecan and Capecitabine, Oxaliplatine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2010to Jan 2014
- Phase
- Phase 1/2
- 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
- Written informed consent obtained prior to study entry?
- Patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas?
- Progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy?
- Former treatment with chemotherapeutic agent containing gemcitabine?
- Is the age of the patient ≥ 18 years?
- Is the ECOG performance status 0-1?
Show all 12Show fewer
- Is the absolute neutrophil count (ANC) ≥ 1.5 x 109/l?
- Is the platelet count ≥ 75 x 109/l?
- Is the total bilirubin ≤1.5 x UNL (upper normal limit)?
- Patient has normal liver function? (If liver metastases are present, there is no upper limit for ALAT/SPGT/alk phosph)?
- Creatinine clearance ≥ 30 ml/min
- Is the patient capable of following the treatment and the plan of evaluation?
Who cannot join
- CTC Grade 3 hyperlipidaemia (>10.34 mmol/l) in spite of treatment
- Active former or concurrent history of malignant neoplasm, in the last 2 years?
- Any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial?
- Pregnant or breast feeding patient (fertile patients must use contraceptives)?
- Infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung disease)
- Known hypersensitivity toward one or more of the parts in the treatment?
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Oncology, Aarhus Hospital
Aarhus, Aarhus, 8000
Department of Oncology, Odense University Hospital
Odense, Odense, 5000
About this study
Official title: A Randomised Fase I/II Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.
- Conditions
- Pancreatic Cancer
- Being tested
- Everolimus, Cetuximab, Irinotecan, Capecitabine, Oxaliplatine
- Keywords
- Pancreas cancer, Everolimus, Irinotecan, Cetuximab, Capecitabine, Oxaliplatin, Gemcitabine resistant pancreascancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus, Cetuximab, IrinotecanDrug
Also called RAD001
Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
Capecitabine, OxaliplatineDrug
Also called Xeloda, Eloxatin
Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly
| Study group | Role | What they receive |
|---|---|---|
| Phase II: Arm A | Experimental | Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B Receives: Drug: Everolimus, Cetuximab, Irinotecan |
| Arm B | Active comparator | Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A. Receives: Drug: Capecitabine, Oxaliplatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)
Measured: 4 months
Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer
Measured: 4 months
Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death
Measured: 18 months
Secondary outcomes (1)
Survival All events grade 1-5 according to NCI-CTCAE in fase I All Adverse events grade 1-5 according to NCI-CTCAEW in Fase II Correlation between effect of treatment and tumourmarkers Quality of life - EORTC QLQ Time to failure of Strategy
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2012
- Study completionJan 2014
Why it stopped: Emergence of FOLFIRINOX and slow recruitment
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Pfeiffer
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Per Pfeiffer, Odense University Hospital
- Investigators
- Per Pfeiffer, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042028
- Sponsor's protocol ID
- ICE
- Status last verified
- Oct 2015
- First submitted
- 4 Jan 2010
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Fase I/II Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01042028
- Acronym / sponsor ID
- ICE
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreas cancer, Everolimus, Irinotecan, Cetuximab, Capecitabine, Oxaliplatin, Gemcitabine resistant pancreascancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Emergence of FOLFIRINOX and slow recruitment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Per PfeifferUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aarhus University Hospital
- Study start
- Jan 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Jan 2010 (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 is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase II: Arm A | Experimental | Drug: Everolimus, Cetuximab, IrinotecanRegime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B |
| Arm B | Active comparator | Drug: Capecitabine, OxaliplatineArm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent obtained prior to study entry?
- Patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas?
- Progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy?
- Former treatment with chemotherapeutic agent containing gemcitabine?
- Is the age of the patient ≥ 18 years?
Key exclusion criteria (6 listed)
- CTC Grade 3 hyperlipidaemia (>10.34 mmol/l) in spite of treatment
- Active former or concurrent history of malignant neoplasm, in the last 2 years?
- Any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial?
- Pregnant or breast feeding patient (fertile patients must use contraceptives)?
- Infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung 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 |
|---|---|---|
| Everolimus, Cetuximab, IrinotecanAlso: RAD001Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage | Drug | Phase II: Arm A |
| Capecitabine, OxaliplatineAlso: Xeloda, EloxatinCapecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly | Drug | Arm B |
Primary outcome
Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)
Time frame: 4 months
Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer
Time frame: 4 months
Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death
Time frame: 18 months
1 secondary outcome
Survival All events grade 1-5 according to NCI-CTCAE in fase I All Adverse events grade 1-5 according to NCI-CTCAEW in Fase II Correlation between effect of treatment and tumourmarkers Quality of life - EORTC QLQ Time to failure of Strategy
Time frame: 22 months
Results and safety
The study was stopped early (reason given: Emergence of FOLFIRINOX and slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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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.
Per Pfeiffer, MD principal investigator
Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Everolimus, Cetuximab, Irinotecan and Capecitabine, Oxaliplatine in people with Pancreatic Cancer, run by Per Pfeiffer at 2 sites in Denmark.
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 12 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: stopped early, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Emergence of FOLFIRINOX and slow recruitment). 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?
Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus) (time frame: 4 months). The study lists 3 primary outcomes in all. 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 20 Oct 2015.