Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin (Re-Play)

Re-Play: Impact of FOLFIRINOX Chemotherapy in IV Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Stage IV
• Intervention / Treatment: Drug: mFOLFIRINOX

Detailed Description

Single-arm phase II study. The chemotherapy regimen with mFOLFIRINOX will be administered every 14 for 4 cycles, after evaluation of tumor response, you can maintain treatment until disease progression.

The FOLFIRINOX regimen, as well as the drugs used (oxaliplatin, 5-Fluorouracil, leucovorin and irinotecan) is already indicated in the package insert for the treatment of colorectal cancer.

If treatment is discontinued after cycle 4 with the patient responding, for response maximum or unmanageable toxicity, it is suggested to maintain imaging control every 60 days (7-day window) until disease progression. This interval is already commonly used for patients with metastatic disease who are on treatment pause. Treatment in progression of illness will be at the discretion of the treating physician. Cancer patients undergoing chemotherapy routinely perform evaluation of organ functions and CEA, as well as clinical evaluation before each cycle of treatment

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01246000
      • Recruiting
      • ICESP
      • Contact: Camila MD Motta, PHD; Phone Number: 55 11 38932000; Email: icesp.pesquisa.np@hc.fm.usp.br
      • Principal Investigator: Paulo MD Hoff, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: mFolfirinox	Drug: mFOLFIRINOX; mFOLFIRINOX: - Oxaliplatin; Leucovorin; Irinotecan and 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess response rate after 4 cycles of FOLFIRINOX	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	2 years
Progression-free survival	2 years

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NP 1950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No