Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin

NCT05354817 | Unknown Phase 2 DMC

• 1 other identifier: NP 1950
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this work is to verify prospectively what the rate of response after triple chemotherapy with mFOLFIRINOX in patients in IV stage of Colorectal Cancer who have already failed after at least two lines of dual combinations with fluoropyrimidine, oxaliplatin, irinotecan and anti-EGFR if wild-type RAS. Currently at ICESP, patients are frequently re-exposed in third line to double combinations.

Conditions

Colorectal Cancer Stage IV

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Assess response rate after 4 cycles of FOLFIRINOX

  2 years

Secondary Outcomes (2)

• Progression-free survival

  2 years

• Overall Survival

  2 years

Study Arms (1)

mFolfirinox

OTHER

Drug: mFOLFIRINOX

Interventions

mFOLFIRINOX DRUG

mFOLFIRINOX: - Oxaliplatin; Leucovorin; Irinotecan and 5-FU

mFolfirinox

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metastatic colon/rectal adenocarcinoma, with measurable by RECIST v. 1.1
• Disease progression to at least two lines of chemotherapy with chemotherapy regimens that contain fluoropyrimidine, irinotecan and oxaliplatin
• Patients with RAS research in tumor sample with result wild animals must have previously received anti-EFGR therapy.
• ECOG (Eastern Cooperative Oncology Group) 0 or 1
• Availability of tumor material for molecular analysis
• Hb \> 8, neutrophils \> 1,500 and PLQ \> 100,000
• Adequate kidney and liver function

You may not qualify if:

• Active neoplasm with other primary site, except in situ tumors
• Contraindication to treatment with fluoropyrimidine, oxaliplatin and irinotecan, including previous unmanageable G3 or greater toxicities, in previous exhibitions.
• Presence of comorbidities that, according to the investigator's assessment, may compromise participant safety
• Prior exposure to the FOLFIRINOX regimen
• Pregnant or lactating women
• Total bilirubin above 1.5mg/dL
• Hepatic transaminases greater than 3 times the upper limit of normality

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

ICESP

São Paulo, São Paulo, 01246000, Brazil

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: October 22, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)