Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Micronutrients

Hematinics

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Aflibercept

Oxaliplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Angiogenesis Inhibitors

Growth Inhibitors

Folate

Vitamin B9

Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.

Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous

AFLIBERCEPT

Clinical Sciences & Operations

Primary Objective:

To evaluate the safety of aflibercept in participants with mCRC treated with irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based regimen (participants similar to those evaluated in the VELOUR trial \[EFC10262, NCT00561470\]) according to side effects prevention and management guidelines.

Secondary Objective:

To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant population.

Each participant was treated until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal for further treatment (whichever come first). Participants were followed-up during treatment and for at least 30 days after its last study treatment (either Aflibercept or FOLFIRI) administration, up to a maximum of 6 months.

Colorectal Cancer Metastatic

A Multicenter, Single Arm, Open Label Clinical Trial Evaluating Safety and Health Related Quality of Life of Aflibercept in Combination With Irinotecan/5-FU Chemotherapy (FOLFIRI) in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the first dose of treatment to 30 days after the last dose of treatment (either Aflibercept or FOLFIRI). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) \& other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health \& quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 \& 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.

EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems \& severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.

EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Baseline corresponded to last evaluable assessment before treatment administration.

Regeneron Pharmaceuticals

Sanofi

Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during 'on-treatment period' (from the first dose of treatment to 30 days after the last dose of treatment \[either aflibercept or FOLFIRI\]).

Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).

Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)

Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.

Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)

Age, Continuous

Sex: Female, Male

Trial Transparency Team

Any TEAE

Any serious TEAE

Any serious related TEAE

Any TEAE leading to death

Any TEAE (permanent treatment discontinuation)

Any TEAE (premature treatment discontinuation)

Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.

Percentage of Participants With Adverse Events (AEs)

Baseline (n=148)

At Cycle 3 (n=130)

At Cycle 5 (n=99)

At Cycle 7 (n=72)

At Cycle 9 (n=51)

At Cycle 11 (n=45)

At Cycle 13 (n=25)

At Cycle 15 (n=24)

At Cycle 17 (n=14)

At Cycle 19 (n=12)

At Cycle 21 (n=10)

At Cycle 23 (n=6)

At Cycle 25 (n=4)

At Cycle 27 (n=4)

At Cycle 29 (n=2)

At Cycle 31 (n=2)

At Cycle 33 (n=1)

At Cycle 35 (n=1)

At Cycle 37 (n=2)

At Cycle 39 (n=2)

At Cycle 41 (n=2)

At Cycle 43 (n=2)

At Cycle 45 (n=2)

At Cycle 47 (n=1)

At end of study treatment (n=73)

EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment(either Aflibercept or FOLFIRI).Here, n=number of participants with available data at specified time-points.

Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

At Cycle 3 (n=127)

At Cycle 5 (n=96)

At Cycle 9 (n=49)

At Cycle 11 (n=43)

At Cycle 13 (n=24)

At Cycle 15 (n=25)

At Cycle 25 (n=3)

At Cycle 27 (n=3)

At Cycle 31 (n=1)

At Cycle 37 (n=1)

At Cycle 39 (n=1)

At Cycle 41 (n=1)

At Cycle 43 (n=1)

At Cycle 45 (n=1)

At end of study treatment (n=71)

EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.

Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score

Baseline (n=125)

At cycle 3 (n=94)

At cycle 5 (n=76)

At cycle 7 (n=57)

At cycle 9 (n=38)

At cycle 11 (n=36)

At cycle 13 (n=22)

At cycle 15 (n=22)

At cycle 17 (n=13)

At cycle 19 (n=10)

At cycle 21 (n=8)

At cycle 23 (n=5)

At cycle 25 (n=2)

At cycle 27 (n=3)

At cycle 29 (n=2)

At cycle 31 (n=1)

At cycle 37 (n=1)

At cycle 39 (n=1)

At cycle 41 (n=1)

At cycle 43 (n=1)

At cycle 45 (n=1)

At end of study treatment (n=55)

Change From Baseline in HRQL EQ-5D-3L VAS Score

Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.

Overall Study

Spots Global Cancer Trial Database for Colorectal Cancer Metastatic

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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