Colorectal CancerPhase 3NCT00469443
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
A Phase 3 study testing Irinotecan, 5-Fluorouracil and Leucovorin in people with Colorectal Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
Trial summary
This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Irinotecan, 5-Fluorouracil and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 8 sitesGreece
- Study dates
- Dec 2006to Feb 2010
- Phase
- Phase 3
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced or metastatic colorectal cancer
- Measurable or evaluable disease
- ECOG performance status ≤ 2
- Age 18 - 72 years
- Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function
- Patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of Avastin
- Patients must be able to understand the nature of this study
- Written informed consent
Who cannot join
- Previous 1st line chemotherapy
- Adjuvant chemotherapy with Irinotecan regimen with relapse < 6 months after the completion
- Active infection
- History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow
- Patients with unstable CNS metastases
Show all 11Show fewer
- Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
- Patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
State General Hospital of Larissa
Larissa
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.
Read the detailed description
There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.
- Conditions
- Colorectal Cancer
- Being tested
- Irinotecan, 5-Fluorouracil, Leucovorin, Capecitabine, Bevacizumab
- Keywords
- Metastatic colorectal cancer, Irinotecan, Capecitabine, Bevacizumab
- 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
Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
5-FluorouracilDrug
Also called 5-FU
5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
LeucovorinDrug
Also called LV
Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
CapecitabineDrug
Also called Xeloda
Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
BevacizumabDrug
Also called Avastin
Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
BevacizumabDrug
Also called Avastin
Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
IrinotecanDrug
Also called CPT-11
Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FOLFIRI/Avastin Receives: Drug: Irinotecan; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Bevacizumab |
| 2 | Experimental | XELIRI/Avastin Receives: Drug: Capecitabine; Drug: Bevacizumab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Progression
Measured: 1 year
Secondary outcomes (5)
Objective Response Rate
Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall Survival
Measured: Probability of 1-year survival (%)
Toxicity profile
Measured: Toxicity assessment on each chemotherapy cycle
Quality of life
Measured: Assessment every two cycles
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 posted4 May 2007 (estimated)
- Study startDec 2006
- Primary completionFeb 2010
- Study completionFeb 2010
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- John Souglakos, MD, Principal investigator, johnsougl@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469443
- Sponsor's protocol ID
- CT/05.16
- Status last verified
- Aug 2010
- First submitted
- 3 May 2007
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Souglakos J, Ziras N, Kakolyris S, Boukovinas I, Kentepozidis N, Makrantonakis P, Xynogalos S, Christophyllakis Ch, Kouroussis Ch, Vamvakas L, Georgoulias V, Polyzos A. Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC). Br J Cancer. 2012 Jan 31;106(3):453-9. doi: 10.1038/bjc.2011.594. Epub 2012 Jan 12.
PubMed 22240792
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00469443
- Acronym / sponsor ID
- CT/05.16
- Conditions
- Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Irinotecan, Capecitabine, Bevacizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Dec 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 May 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 phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.
Detailed description
There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.
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: Irinotecan, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: BevacizumabFOLFIRI/Avastin |
| 2 | Experimental | Drug: Capecitabine, Drug: Bevacizumab, Drug: IrinotecanXELIRI/Avastin |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed locally advanced or metastatic colorectal cancer
- Measurable or evaluable disease
- ECOG performance status ≤ 2
- Age 18 - 72 years
- Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function
Key exclusion criteria (11 listed)
- Previous 1st line chemotherapy
- Adjuvant chemotherapy with Irinotecan regimen with relapse < 6 months after the completion
- Active infection
- History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow
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-11Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles | Drug | 1 |
| 5-FluorouracilAlso: 5-FU5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles | Drug | 1 |
| LeucovorinAlso: LVLeucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles | Drug | 1 |
| CapecitabineAlso: XelodaCapecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles | Drug | 2 |
| BevacizumabAlso: AvastinBevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles | Drug | 1 |
| BevacizumabAlso: AvastinBevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles | Drug | 2 |
| IrinotecanAlso: CPT-11Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles | Drug | 2 |
Primary outcome
Time To Progression
Time frame: 1 year
5 secondary outcomes
Objective Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall Survival
Time frame: Probability of 1-year survival (%)
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Quality of life
Time frame: Assessment every two cycles
Symptoms improvement
Time frame: Assessment every two cycles
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 19 Aug 2010.
- Derived from this study: PubMed 22240792Souglakos J, Ziras N, Kakolyris S, Boukovinas I, Kentepozidis N, Makrantonakis P, Xynogalos S, Christophyllakis Ch, Kouroussis Ch, Vamvakas L, Georgoulias V, Polyzos A. Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC). Br J Cancer. 2012 Jan 31;106(3):453-9. doi: 10.1038/bjc.2011.594. Epub 2012 Jan 12.
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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
johnsougl@gmail.com
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irinotecan, 5-Fluorouracil and Leucovorin in people with Colorectal 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 8 inclusion and 11 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 19 Aug 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time To Progression (time frame: 1 year). 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 NCT00469443, 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 19 Aug 2010.