Metastatic Colorectal CancerPhase 2NCT00689624
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer
A Phase 2 study testing Irinotecan, Leukovorin and Oxaliplatin in people with Metastatic Colorectal Cancer, run by University Hospital of Crete at 1 site in Greece.
Trial summary
This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Irinotecan, Leukovorin and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2007to Dec 2010
- 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
- Patients with histologically proven metastatic adenocarcinoma of the colon or rectum
- Previous chemotherapy for metastatic disease not allowed. Patients who received prior adjuvant 5-FU-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy
- Patients with operable metastatic disease are excluded from the study
- Age 18-70 years
- Performance status (ECOG) 0-1
- At least one bidimensionally measurable lesion of >= 2cm
Show all 10Show fewer
- Life expectancy of at least 6 months
- Adequate hematologic parameters (absolute neutrophil count >= 1.5x109/L and platelets >=100x109/L)
- Creatinine and total bilirubin < 1.25 times the upper limit of normal
- Aspartate and alanine aminotransferase < 3.0 times the upper limit of normal (<5 times in case of liver mets)
Who cannot join
- Absence of active infection or malnutrition (loss of more than 20% of the body weight)
- No history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
- Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields.
- Patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded.
- All patients will have to sign written informed consent in order to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Triplet Combination With Irinotecan Plus Oxaliplatin,Continuous Infusion 5-Fluorouracil And Leucovorin Plus Cetuximab As First Line Treatment In Metastatic Colorectal Cancer. A Pilot Phase II Trial
This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.
Read the detailed description
The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Irinotecan, Leukovorin, Oxaliplatin, 5-FLUOROURACIL, Cetuximab
- Keywords
- Colorectal Cancer, Cetuximab, FOLFOXIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called CPT-11, Campto
Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
LeukovorinDrug
Also called LV
Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
OxaliplatinDrug
Also called LoHP, Eloxatin
Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
5-FLUOROURACILDrug
Also called 5-FU
5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3
CetuximabDrug
Also called Erbitux
Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FOLFOXIRI+Erbitux Receives: Drug: Irinotecan; Drug: Leukovorin; Drug: Oxaliplatin; Drug: 5-FLUOROURACIL; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: 2 months
Secondary outcomes (6)
Resectability rates
Measured: Resectability at the end of treatment (4 or 6 months from the entry to the study)
Time to Tumor Progression
Measured: 1 year
Overall Survival
Measured: 1 year
Toxicity profile
Measured: Toxicity assessment on each chemotherapy cycles (every 15 days)
Pharmacogenomic analysis
Measured: During the treatment
Q-Twist analysis of Quality of life
Measured: Quality of life assessment every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vassilis Georgoulias, MD, University Hospital of Crete
- Investigators
- John Souglakos, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689624
- Sponsor's protocol ID
- CT/06.21
- Status last verified
- Sep 2015
- First submitted
- 29 May 2008
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triplet Combination With Irinotecan Plus Oxaliplatin,Continuous Infusion 5-Fluorouracil And Leucovorin Plus Cetuximab As First Line Treatment In Metastatic Colorectal Cancer. A Pilot Phase II Trial
- ClinicalTrials.gov ID
- NCT00689624
- Acronym / sponsor ID
- CT/06.21
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal Cancer, Cetuximab, FOLFOXIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jun 2008 (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 evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.
Detailed description
The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Irinotecan, Drug: Leukovorin, Drug: Oxaliplatin, Drug: 5-FLUOROURACIL, Drug: CetuximabFOLFOXIRI+Erbitux |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically proven metastatic adenocarcinoma of the colon or rectum
- Previous chemotherapy for metastatic disease not allowed. Patients who received prior adjuvant 5-FU-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy
- Patients with operable metastatic disease are excluded from the study
- Age 18-70 years
- Performance status (ECOG) 0-1
Key exclusion criteria (5 listed)
- Absence of active infection or malnutrition (loss of more than 20% of the body weight)
- No history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
- Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields.
- Patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded.
- All patients will have to sign written informed consent in order to participate in the study
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 |
|---|---|---|
| IrinotecanAlso: CPT-11, CamptoIrinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1 | Drug | 1 |
| LeukovorinAlso: LVLeukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3 | Drug | 1 |
| OxaliplatinAlso: LoHP, EloxatinOxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV | Drug | 1 |
| 5-FLUOROURACILAlso: 5-FU5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3 | Drug | 1 |
| CetuximabAlso: ErbituxCetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy | Drug | 1 |
Primary outcome
Objective Response Rate
Time frame: 2 months
6 secondary outcomes
Resectability rates
Time frame: Resectability at the end of treatment (4 or 6 months from the entry to the study)
Time to Tumor Progression
Time frame: 1 year
Overall Survival
Time frame: 1 year
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycles (every 15 days)
Pharmacogenomic analysis
Time frame: During the treatment
Q-Twist analysis of Quality of life
Time frame: Quality of life assessment every 8 weeks
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 28 Sep 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.
John Souglakos, MD principal investigator
University Hospital of Crete
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 Irinotecan, Leukovorin and Oxaliplatin in people with Metastatic Colorectal Cancer, run by University Hospital of Crete at 1 site 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 10 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 28 Sep 2015. 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 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 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: 2 months). 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 28 Sep 2015.