Clinical trial · Interventional
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
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
NCT00457691CI-TRIAL-00017307completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| levo- leucovorin | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: 5 fluorouracil
- Drug: irinotecan
- Drug: levo- leucovorin
- Drug: sunitinib
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: 5 fluorouracil
- Drug: irinotecan
- Drug: levo- leucovorin
- Drug: placebo
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- First dose of study treatment up to 30 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDCarrato 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. PMID 23358972