Metastatic Colorectal CancerPhase 3NCT00457691
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
A Phase 3 study testing 5 fluorouracil, irinotecan and levo- leucovorin in people with Metastatic Colorectal Cancer, run by Pfizer at 132 sites in 34 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- 5 fluorouracil, irinotecan and levo- leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 768 participants
- Where
- 132 sitesin 34 countries
- Study dates
- Jun 2007to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
- Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
- Adequate organ function defined by blood test.
Who cannot join
- History of another primary cancer in the last 3 years.
- Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
- History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.
Trial locations and contacts
132 sites in 34 countries.
132 sites in 34 countries
Germany9 sites
Pfizer Investigational Site
Berlin, 12203
Pfizer Investigational Site
Bochum, 44892
Pfizer Investigational Site
Esslingen am Neckar, 73730
Pfizer Investigational Site
Frankfurt, 60590
Pfizer Investigational Site
Halle, 06120
Pfizer Investigational Site
Hanover, 30625
Pfizer Investigational Site
Mönchengladbach, 41063
Pfizer Investigational Site
Oldenburg, 26133
Pfizer Investigational Site
Regensburg, 93049
Taiwan9 sites
Pfizer Investigational Site
Changhua, 500
Pfizer Investigational Site
Chiayi County, 613
Pfizer Investigational Site
Kaohsiang Hsien, Taiwan, 833
Pfizer Investigational Site
Kaohsiung City, 813
Pfizer Investigational Site
Kwei-Shan, Taoyuan
Pfizer Investigational Site
Taichung, 40705
Pfizer Investigational Site
Tainan, 736
Pfizer Investigational Site
Taipei, 112
Pfizer Investigational Site
Taipei
Spain8 sites
Pfizer Investigational Site
Alicante, Alicante, 03010
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
Elche, Alicante, 03202
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Móstoles, Madrid, 28935
Pfizer Investigational Site
Santander, Cantabria, 39008
Pfizer Investigational Site
Seville, Sevilla, 41013
Pfizer Investigational Site
Zaragoza, Zaragoza, 50009
South Korea7 sites
Pfizer Investigational Site
Daegu, 700-712
Pfizer Investigational Site
Goyang-si, Gyeonggi-do, 410-769
Pfizer Investigational Site
Incheon, 405-760
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736
Bulgaria6 sites
Pfizer Investigational Site
Rousse, 7002
Pfizer Investigational Site
Sofia, Bulgaria, 1504
Pfizer Investigational Site
Sofia, 1233
Pfizer Investigational Site
Sofia, 1756
Pfizer Investigational Site
Stara Zagora, 6003
Pfizer Investigational Site
Varna, 9000
India6 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 078
Pfizer Investigational Site
Mumbai, Maharashtra, 400 012
Pfizer Investigational Site
Mumbai, Maharashtra, 400026
Pfizer Investigational Site
Pune, Maharashtra, 411 001
Pfizer Investigational Site
Pune, Maharashtra, 411 016
Pfizer Investigational Site
Vellore, Tamil Nadu, 632 004
Belgium5 sites
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, 4000
Brazil5 sites
Pfizer Investigational Site
Curitiba, Paraná, 80530-010
Pfizer Investigational Site
Goiânia, Goiás, 74075-040
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20230-130
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20231 -050
Pfizer Investigational Site
Santo André, São Paulo, 09060-650
Hungary5 sites
Pfizer Investigational Site
Budapest, 1106
Pfizer Investigational Site
Budapest, 1115
Pfizer Investigational Site
Budapest, 1122
Pfizer Investigational Site
Debrecen, 4032
Pfizer Investigational Site
Debrecen, 4043
Russia5 sites
Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Moscow, 123423
Pfizer Investigational Site
Saint Petersburg, 191104
Pfizer Investigational Site
Saint Petersburg, 195067
Pfizer Investigational Site
Saint Petersburg, 197758
South Africa5 sites
Pfizer Investigational Site
Observatory, 7925
Pfizer Investigational Site
Panorama, 7500
Pfizer Investigational Site
Parktown, 2193
Pfizer Investigational Site
Port Elizabeth, 6045
Pfizer Investigational Site
Sandton, 2199
Ukraine5 sites
Pfizer Investigational Site
Cherkasy, 18009
Pfizer Investigational Site
Dnipropetrovsk, 49102
Pfizer Investigational Site
Kyiv, 03022
Pfizer Investigational Site
Lviv, 79031
Pfizer Investigational Site
Uzhhorod, 88014
Australia4 sites
Pfizer Investigational Site
East Bentleigh, Victoria, 3165
Pfizer Investigational Site
Frankston, Victoria, 3199
Pfizer Investigational Site
Fremantle, Western Australia, 6160
Pfizer Investigational Site
Wollongong, New South Wales, 2500
Ireland4 sites
Pfizer Investigational Site
Dublin, 8
Pfizer Investigational Site
Dublin, 9
Pfizer Investigational Site
Dublin
Pfizer Investigational Site
Galway
Portugal4 sites
Pfizer Investigational Site
Evora, 7000-811
Pfizer Investigational Site
Porto, 4099-001
Pfizer Investigational Site
Porto, 4200-072
Pfizer Investigational Site
Santa Maria da Feira, 4520-211
Serbia4 sites
Pfizer Investigational Site
Belgrade, Serbia, 11000
Pfizer Investigational Site
Belgrade, 11000
Pfizer Investigational Site
Kamenitz, Serbia, 21204
Pfizer Investigational Site
Kamenitz, 21204
Thailand4 sites
Pfizer Investigational Site
Bangkok, 10700
Pfizer Investigational Site
Muang, Changwat Khon Kaen, 40002
Pfizer Investigational Site
Muang, Chiang Mai, 50200
Pfizer Investigational Site
Rachathevee, Bangkok, 10400
Czechia3 sites
Pfizer Investigational Site
Brno, 65653
Pfizer Investigational Site
Nová Ves pod Pleší, 26204
Pfizer Investigational Site
Příbram, 26105
Hong Kong3 sites
Pfizer Investigational Site
Hong Kong
Pfizer Investigational Site
Kowloon
Pfizer Investigational Site
Tuen Mun, New Territories, 0
Mexico3 sites
Pfizer Investigational Site
Acapulco de Juárez, Guerrero, 39670
Pfizer Investigational Site
Ciudad Obregón, Sonora, 85000
Pfizer Investigational Site
Mexico City, Mexico City, 14080
Poland3 sites
Pfizer Investigational Site
Warsaw, 00-909
Pfizer Investigational Site
Warsaw, 02-097
Pfizer Investigational Site
Warsaw, 02-781
Sweden3 sites
Pfizer Investigational Site
Gothenburg, 416 85
Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Uppsala, 751 85
United Kingdom3 sites
Pfizer Investigational Site
London, NW1 2PQ
Pfizer Investigational Site
Manchester, M20 4BX
Pfizer Investigational Site
Northwood, Middlesex, HA6 2RN
Argentina2 sites
Pfizer Investigational Site
La Plata, Buenos Aires, B1902AVQ
Pfizer Investigational Site
Santa Fe, Santa Fe Province, S3000FFU
Austria2 sites
Pfizer Investigational Site
Sankt Pölten, 3100
Pfizer Investigational Site
Vienna, 1020
Canada2 sites
Pfizer Investigational Site
Oshawa, Ontario, L1G 2B9
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6
Chile2 sites
Pfizer Investigational Site
Santiago, RM, 7510032
Pfizer Investigational Site
Santiago, RM
Colombia2 sites
Pfizer Investigational Site
Medellín, Antioquia, 0
Pfizer Investigational Site
Pasto, Departamento de Nariño, 0
Norway2 sites
Pfizer Investigational Site
Førde, 6807
Pfizer Investigational Site
Tønsberg, 3103
Singapore2 sites
Pfizer Investigational Site
Singapore, Singapore, 119074
Pfizer Investigational Site
Singapore, Singapore, 169610
Slovakia2 sites
Pfizer Investigational Site
Bratislava, 81250
Pfizer Investigational Site
Bratislava, 833 10
Bosnia and Herzegovina1 site
Pfizer Investigational Site
Sarajevo, 71000
About this study
Official title: A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
Read the detailed description
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- 5 fluorouracil, irinotecan, levo- leucovorin, sunitinib, placebo
- Keywords
- colorectal neoplasms
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 fluorouracilDrug
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
irinotecanDrug
180mg/m2 iv day 1 every 14 days
levo- leucovorinDrug
200mg/m2 iv; day 1 every 14 days
sunitinibDrug
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
5 fluorouracilDrug
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
irinotecanDrug
180mg/m2 iv day 1 every 14 days
levo- leucovorinDrug
200mg/m2 iv; day 1 every 14 days
placeboDrug
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 5 fluorouracil; Drug: irinotecan; Drug: levo- leucovorin; Drug: sunitinib |
| 2 | Placebo comparator | Not described Receives: Drug: 5 fluorouracil; Drug: irinotecan; Drug: levo- leucovorin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
Measured: First dose of study treatment up to 30 months
Secondary outcomes (7)
Overall Survival (OS)
OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.
Measured: Baseline up to 30 months
Number of Participants With Overall Confirmed Objective Response
Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Day 28 of Cycle 1 up to 30 months
Duration of Response (DR)
DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Measured: Day 28 of Cycle 1 up to 30 months
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).
Measured: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
Change From Baseline in MDASI-GI Symptom Interference Score
Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).
Measured: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state.
Measured: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Measured: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2010
- Study completionMar 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 768 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
- NCT00457691
- Sponsor's protocol ID
- A6181122
- Status last verified
- Mar 2015
- First submitted
- 4 Apr 2007
- Last updated
- 30 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M, Lim R, Roman L, Shparyk Y, Bondarenko I, Jonker DJ, Sun Y, De la Cruz JA, Williams JA, Korytowsky B, Christensen JG, Lin X, Tursi JM, Lechuga MJ, Van Cutsem E. Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol. 2013 Apr 1;31(10):1341-7. doi: 10.1200/JCO.2012.45.1930. Epub 2013 Jan 28.
PubMed 23358972
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
- ClinicalTrials.gov ID
- NCT00457691
- Acronym / sponsor ID
- A6181122
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Posted 3 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
Detailed description
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 5 fluorouracil, Drug: irinotecan, Drug: levo- leucovorin, Drug: sunitinib |
| 2 | Placebo comparator | Drug: 5 fluorouracil, Drug: irinotecan, Drug: levo- leucovorin, Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
- Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
- Adequate organ function defined by blood test.
Key exclusion criteria (3 listed)
- History of another primary cancer in the last 3 years.
- Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
- History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal 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 |
|---|---|---|
| 5 fluorouracil400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days | Drug | 1 |
| irinotecan180mg/m2 iv day 1 every 14 days | Drug | 1 |
| levo- leucovorin200mg/m2 iv; day 1 every 14 days | Drug | 1 |
| sunitinib37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period | Drug | 1 |
| 5 fluorouracil400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days | Drug | 2 |
| irinotecan180mg/m2 iv day 1 every 14 days | Drug | 2 |
| levo- leucovorin200mg/m2 iv; day 1 every 14 days | Drug | 2 |
| placebo37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period | Drug | 2 |
Primary outcome
Progression-free Survival (PFS)
Time frame: First dose of study treatment up to 30 months
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
7 secondary outcomes
Overall Survival (OS)
Time frame: Baseline up to 30 months
Number of Participants With Overall Confirmed Objective Response
Time frame: Day 28 of Cycle 1 up to 30 months
Duration of Response (DR)
Time frame: Day 28 of Cycle 1 up to 30 months
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
Time frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
Change From Baseline in MDASI-GI Symptom Interference Score
Time frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
Time frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
Time frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23358972Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M, Lim R, Roman L, Shparyk Y, Bondarenko I, Jonker DJ, Sun Y, De la Cruz JA, Williams JA, Korytowsky B, Christensen JG, Lin X, Tursi JM, Lechuga MJ, Van Cutsem E. Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol. 2013 Apr 1;31(10):1341-7. doi: 10.1200/JCO.2012.45.1930. Epub 2013 Jan 28.
- 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
132 sites in 34 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5 fluorouracil, irinotecan and levo- leucovorin in people with Metastatic Colorectal Cancer, run by Pfizer at 132 sites in 34 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 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in Germany, Taiwan, Spain, South Korea, Bulgaria and 29 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. Some participants in this study may receive a placebo. 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 3 Jun 2011). 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?
Progression-free Survival (PFS) (time frame: First dose of study treatment up to 30 months). 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 NCT00457691, 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 30 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.