A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

Sanofi

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer Metastatic

Treatments: Drug: 5-FU; Drug: Aflibercept; Drug: Levofolinate; Drug: Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01882868

U1111-1120-0173 (Other Identifier)

EFC11885

Details and patient eligibility

About

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.

Full description

Screening was up to 24 days. Treatment period was continued until DP, unacceptable toxicity, or participant's refusal. Follow up period was continued until death, participant's refusal, or end of study, whichever came first.

This trial was conducted in Japan, where the International Nonproprietary Name (INN) designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".

Enrollment: 62 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Aflibercept + FOLFIRI

Experimental group

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.

Treatment:

Drug: Levofolinate

Drug: Irinotecan

Drug: 5-FU

Drug: Aflibercept