A Comparison of mXELIRI Regimen and FOLFIRI Combined Bevacizumab Regimen as First-line Chemotherapy Regimen for Metastatic Colorectal Cancer

NCT04247984 | Completed Phase 2

• 1 other identifier: NCC-000583
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, multicenter，randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI as first-line treatment in patients with metastatic colorectal cancer (mCRC).

Conditions

Metastatic Colorectal Cancer

Keywords

XELIRI; FOLFIRI

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.

  6 Months

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  6 Months

• Overall survival (OS)

  1 Year

• Incidence of Adverse Events

  6 Months

• Quality of life (QoL) Questionnaire

  6 Months

Study Arms (2)

mXELIRI+ Bevacizumab

EXPERIMENTAL

Biological: Bevacizumab; Drug: Capecitabine; Drug: Irinotecan

FOLFIRI + Bevacizumab

ACTIVE COMPARATOR

Biological: Bevacizumab; Drug: Irinotecan; Drug: 5-FU; Drug: CF

Interventions

Bevacizumab BIOLOGICAL

5 mg/kg intravenously administered on day 1 of a 2-week cycle.

Also known as: Avastin

FOLFIRI + Bevacizumab; mXELIRI+ Bevacizumab

Capecitabine DRUG

2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.

Also known as: Xeloda

mXELIRI+ Bevacizumab

Irinotecan DRUG

180 mg/m2 intravenously administered on day 1 of a 2-week cycle.

Also known as: CPT-11

FOLFIRI + Bevacizumab

5-FU DRUG

400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.

Also known as: Fluorouracil

FOLFIRI + Bevacizumab

CF DRUG

300 mg/m2 intravenously administered on day 1 of a 2-week cycle.

FOLFIRI + Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Signed informed consent;
• ECOG≤1;
• Age≥18；
• Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no previous chemotherapy or molecular targeted therapy;
• At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
• life expectancy \>12 weeks;
• Adequate bone marrow and organ function. Hb≥9 G/L; Absolute neutrophil ≥ 1.5 G/L; PLT ≥100 G/L ;ALT/AST ≤2 ULN or ≤5ULN with liver metastases;ALP ≤2.5 ULN or ≤5ULN with liver metastases or ≤10ULN with bone metastases ; TBIL ≤1.5 ULN; Cr≤1.0 ULN;

You may not qualify if:

• Pregnant or lactating women；
• Sexually active women (of childbearing potential) or men unwilling to adopt an effective method of birth control during the course of the study；
• Previous treatment with Irinotecan or anti-VEGF antibodies;
• Any previous malignancy within 5 years prior to study entry, except for cured basal cell carcinoma of skin or carcinoma-in-situ of the uterine cervix;
• History of acute coronary syndromes (including myocardial infarction and unstable angina) within 6 months prior to study entry, or history or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association (NYHA);
• Uncontrolled hypertension and severe arrhythmia requiring drug treatment;
• Present with non-healing fractures or wounds of skin;
• History of previous abdominal fistula, gastrointestinal perforation or intra-abdominal abscesses within 6 months before randomization;
• Major surgery, open surgical biopsy or significant traumatic injury within 4 weeks or needle biopsy within 7 days before randomization before randomization；
• Evidence or history of bleeding diathesis or coagulopathy；
• Known or suspected allergy or hypersensitivity to any component of Bevacizumab, xeloda, irinotecan, or 5-FU/LV;
• Clinical or radiological evidence of CNS metastases;
• History of unexpected serious adverse events to fluoropyrimidine treatments or known dihidropyrimidine dehydrogenase (DPD) deficiency;
• Patients subjected to organ allografts who require immunosuppressive treatment;
• Prior adjuvant or neoadjuvant treatment for metastatic colorectal cancer is allowed, as long as it has concluded at least 6 months before beginning the treatment of the study;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Beijing Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator

Study Sites (1)

Cancer Hospital & Institute, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: May 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: January 31, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

CN (1)