Colorectal NeoplasmsPhase 3NCT00143403
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
A Phase 3 study testing Irinotecan + 5 FU + folinic acid and Folinic Acid + 5 FU in people with Colorectal Neoplasms and Liver Neoplasms, run by Pfizer at 66 sites in 16 countries.
Trial summary
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Liver Neoplasms
- What is being tested?
- Irinotecan + 5 FU + folinic acid and Folinic Acid + 5 FU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 66 sitesin 16 countries
- Study dates
- Dec 2001to Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 proven adenocarcinoma of the colon or rectum with complete resection of primary tumour.
- Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
- Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.
Who cannot join
- Prior hepatic radiation or resection.
- Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
- Prior chemotherapy for metastatic disease.
Trial locations and contacts
66 sites in 16 countries.
66 sites in 16 countries
France16 sites
Pfizer Investigational Site
Amiens, 80054
Pfizer Investigational Site
Avignon, 84000
Pfizer Investigational Site
Boulogne-Billancourt
Pfizer Investigational Site
Clermont-Ferand Cedex 1, 63058
Pfizer Investigational Site
Colmar, 68024
Pfizer Investigational Site
Grenoble, 38043
Pfizer Investigational Site
Marseille, 13005
Pfizer Investigational Site
Marseille, 13273 CEDEX 09
Pfizer Investigational Site
Marseille, 13273
Pfizer Investigational Site
Montpellier, 34295
Pfizer Investigational Site
Montpellier, 34298 CEDEX 5
Pfizer Investigational Site
Nice, 06031
Pfizer Investigational Site
Nîmes, 30900
Pfizer Investigational Site
Rennes, 35042
Pfizer Investigational Site
Strasbourg, 67091
Pfizer Investigational Site
Toulouse, 31059
Germany11 sites
Pfizer Investigational Site
Cottbus, 03048
Pfizer Investigational Site
Dessau, 06847
Pfizer Investigational Site
Erlangen, 91054
Pfizer Investigational Site
Hamburg, 20246
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Magdeburg, 39104
Pfizer Investigational Site
Magdeburg, 39120
Pfizer Investigational Site
Mainz, 55131
Pfizer Investigational Site
Oldenburg, 26133
Pfizer Investigational Site
Regensburg, 93042
Pfizer Investigational Site
Tübingen, 72076
Italy8 sites
Pfizer Investigational Site
Brescia, 25123
Pfizer Investigational Site
Carpi, Modena, 41012
Pfizer Investigational Site
Latisana, UD, 33053
Pfizer Investigational Site
Padova, 35100
Pfizer Investigational Site
Parma, 43100
Pfizer Investigational Site
Piacenza, 29100
Pfizer Investigational Site
Reggio Emilia, 42100
Pfizer Investigational Site
Rozzano (Mi), 20089
Israel5 sites
Pfizer Investigational Site
Haifa
Pfizer Investigational Site
Petah Tikva
Pfizer Investigational Site
Rehovot, 76100
Pfizer Investigational Site
Tel Aviv, 64239
Pfizer Investigational Site
Tel HaShomer
South Korea5 sites
Pfizer Investigational Site
Daegu, 700-721
Pfizer Investigational Site
Goyang, 411764
Pfizer Investigational Site
Seoul, 120-753
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 139-240
Spain5 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Santander, Cantabria, 39008
Pfizer Investigational Site
Seville, Sevilla, 41014
Denmark3 sites
Pfizer Investigational Site
Copenhagen, 2100
Pfizer Investigational Site
Herlev, DK-2730
Pfizer Investigational Site
Odense, DK5000
United Kingdom3 sites
Pfizer Investigational Site
London, N18 1QX
Pfizer Investigational Site
Southampton, SO16 6YD
Pfizer Investigational Site
Surrey, GU2 7XX
Belgium2 sites
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Roeselare, 8800
Ukraine2 sites
Pfizer Investigational Site
Donetsk, Ukraine, 83092
Pfizer Investigational Site
Kiev, 03922
About this study
Official title: Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.
- Conditions
- Colorectal Neoplasms, Liver Neoplasms
- Being tested
- Irinotecan + 5 FU + folinic acid, Folinic Acid + 5 FU
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan + 5 FU + folinic acidDrug
irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Folinic Acid + 5 FUDrug
folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Irinotecan + 5 FU + folinic acid |
| 2 | Active comparator | Not described Receives: Drug: Folinic Acid + 5 FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Measured: last tumor assessment date or cut-off date, whichever is earlier.
Secondary outcomes (1)
Overall Survival Rates
Probability of being alive was calculated in a yearly increment.
Measured: Median follow-up time (42 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionFeb 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143403
- Sponsor's protocol ID
- CPT-GMA-301
- Other IDs
- A5961076
- Status last verified
- Sep 2010
- First submitted
- 1 Sep 2005
- Last updated
- 28 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT00143403
- Acronym / sponsor ID
- CPT-GMA-301
- Conditions
- Colorectal Neoplasms, Liver Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Feb 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Posted 1 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.
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 + 5 FU + folinic acid |
| 2 | Active comparator | Drug: Folinic Acid + 5 FU |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour.
- Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
- Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.
Key exclusion criteria (3 listed)
- Prior hepatic radiation or resection.
- Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
- Prior chemotherapy for metastatic 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 |
|---|---|---|
| Irinotecan + 5 FU + folinic acidirinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks | Drug | 1 |
| Folinic Acid + 5 FUfolinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks | Drug | 2 |
Primary outcome
Disease Free Survival (DFS)
Time frame: last tumor assessment date or cut-off date, whichever is earlier.
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
1 secondary outcome
Overall Survival Rates
Time frame: Median follow-up time (42 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
66 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irinotecan + 5 FU + folinic acid and Folinic Acid + 5 FU in people with Colorectal Neoplasms and Liver Neoplasms, run by Pfizer at 66 sites in 16 countries.
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 3 inclusion and 3 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 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in France, Germany, Italy, Israel, South Korea and 11 more countries. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Free Survival (DFS) (time frame: last tumor assessment date or cut-off date, whichever is earlier.). 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 2010.