Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer

NCT04810585 | Unknown Phase 4

• 1 other identifier: 4-2019-1285
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the pervious data, aflibercept in combination with FOLFIRI is one of the effective 2nd line treatment option in advanced colorectal cancer. In this study, we prospectively assess the efficacy of 2nd line aflibercept in combination with FOLFIRI in advanced colorectal cancer in terms of progression-free survival. We further assess the efficacy according to the type of 1st line treatment. plasma biomarker study (HGF, VEGF-A, VEGF-D, IFN-γ, Angiopoietin-2, sICAM-1, sVCAM-1, TIMP-1, PIGF (HS), IL-6 (HS), IL-8 (HS), sNeuropilin-1, Thrombospondin-2 , Osteopontin , sVEGFR1, sVEGFR2, sVEGFR3) , overall survival (OS)OS, objective response rate (ORR), and safety are also assessed as the 2ndary objectives.

Conditions

Recurrent or Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  progressive disease (PD) or death, whichever occurs first. Results will be summarized by arm * Kaplan-Meier method for survival function estimate * Stratified Cox proportional hazard regression for hazard ratio (HR) estimate

  up to 5years

Secondary Outcomes (4)

• Overall Survival (OS)

  up to 5years

• ORR (Objective Response Rate)

  up to 5years

• Incidence of Adverse events (Safety)/ vital sign(Safety)/ ECOG PS(Safety)

  up to 5years

• Prognostic or Predictive Biomarker for Aflibercept (plasma biomarker)

  up to 5years

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Aflibercept + FOLFIRI

Interventions

Aflibercept + FOLFIRI DRUG

Day 1. Aflibercept + FOLFIRI * aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus) * Folinic acid: 400 mg/m2 IV infusion for over 2 hours * Irinotecan: 150 mg/m2 IV infusion for over 1 hours * 5-FU: 400 mg/m2 IV bolus injection for over 5 minute * 5-FU: 2400 mg/m2 IV continuous infusion for 46 hours every 2 weeks until progression disease or death or unacceptable toxicity

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is an adult, ≥ 19 years old at the time of informed consent
• Patient has histologically confirmed advanced adenocarcinoma of colon or rectum
• Patients who were failed in only one treatment with target agent (anti-EGFR Ab or anti-VEGF Ab) combined with FOLFOX
• At least one measurable disease, as defined by RECIST version 1.1
• ECOG PS of 0 to 2.
• Life expectancy ≥ 3 months.
• Acceptable hematologic status (without growth factor support or transfusion dependency):
• ANC ≧ 1.5 x 109/L,
• Platelet count ≧100 x 109/L
• Hemoglobin ≧9.0 g/dL.
• Acceptable liver function:
• Bilirubin ≤ 1.0 x upper limit of normal(ULN)
• AST, ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN in case of liver metastasis
• Serum creatinine ≤ 1.0 x UNL
• Patients who understand study protocol and signed informed consents.

You may not qualify if:

• Previous therapy with other VEGFR inhibitors (other than bevacizumab) or irinotecan
• Patients who have serious underlying co-morbidities which could cause end-organ dysfunction, interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in this study. in the opinion of the Investigator
• Contraindications to the use of FOLFIRI or aflibercept
• Female patients who are pregnant or breast feeding, or male/female patients of reproductive potential who are not willing to employ effective birth control
• Patients who are unable to read the study consent

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Recurrence; Colorectal Neoplasms

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Joong Bae Ahn, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joong Bae Ahn, MD, PhD

CONTACT

82-2-2228-8134; vvswm513@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 23, 2021
• Study Start: April 20, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)