Clinical trial · Interventional
A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan
A Single-Arm Phase II Study in Japan to Assess the Efficacy and Safety of Aflibercept Administered Every Two Weeks in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Who Progressed During or Following an Oxaliplatin-Based Regimen
NCT01882868CI-TRIAL-00026437completedPhase 2Results 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)
Primary Objective: To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by objective response rate (ORR). Secondary Objective: To assess the following: * safety profile; * progression free survival (PFS); * overall survival (OS); * pharmacokinetics (PK); * immunogenicity.
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 |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Aflibercept | Drug | Aflibercept | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Levofolinate | Drug | Levoleucovorin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aflibercept + FOLFIRI
- description
- Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m\^2 (2 hours) and irinotecan 180 mg/m\^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m\^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m\^2.
- interventionNames
- Drug: Aflibercept
- Drug: Levofolinate
- Drug: Irinotecan
- Drug: 5-FU
Primary outcomes (1)
- measure
- Percentage of Participants With Overall Response
- timeFrame
- Baseline and every 6 weeks until DP (maximum duration: 16.4 months)
- description
- Overall response in participants was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) assessed by an independent radiological review committee (IRRC) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions; any lymph node (target or non-target) must have reduction in the short axis to \<10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall response and the 95% confidence interval (CI) were provided. The 95% CI was calculated using normal approximation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria: * Histologically or cytologically proven adenocarcinoma of the colon or rectum. * Metastatic disease that was not amenable to potentially curative treatment. * Participants with measurable disease. * One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease. * Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy were also eligible. Exclusion criteria: * Prior therapy with irinotecan. * Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior chemotherapy to the time of registration. * Unresolved toxicity (grade \>1) from prior anticancer therapy. * Eastern Cooperative Oncology Group (ECOG) performance status \>1. * Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis. * Other prior malignancy. * Pregnant or breast-feeding women. * Uncontrolled hypertension. * Inadequate bone marrow function, liver function, or renal function. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
References
Publications (2)
- DERIVEDHamaguchi T, Denda T, Kudo T, Sugimoto N, Ura T, Yamazaki K, Fujii H, Kajiwara T, Nakajima TE, Takahashi S, Otsu S, Komatsu Y, Nagashima F, Moriwaki T, Esaki T, Sato T, Itabashi M, Oki E, Sasaki T, Chiron M, Yoshino T. Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer. Cancer Sci. 2019 Nov;110(11):3565-3572. doi: 10.1111/cas.14198. Epub 2019 Oct 21. PMID 31520559
- DERIVEDDenda T, Sakai D, Hamaguchi T, Sugimoto N, Ura T, Yamazaki K, Fujii H, Kajiwara T, Nakajima TE, Takahashi S, Otsu S, Komatsu Y, Nagashima F, Moriwaki T, Esaki T, Sato T, Itabashi M, Oki E, Sasaki T, Sunaga Y, Ziti-Ljajic S, Brillac C, Yoshino T. Phase II trial of aflibercept with FOLFIRI as a second-line treatment for Japanese patients with metastatic colorectal cancer. Cancer Sci. 2019 Mar;110(3):1032-1043. doi: 10.1111/cas.13943. Epub 2019 Feb 22. PMID 30657223