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

NCT ID: NCT05354817

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2023-12-31

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.

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

Conditions

Colorectal Cancer Stage IV

Keywords

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mFolfirinox

Group Type: OTHER

mFOLFIRINOX

Intervention Type: DRUG

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

Interventions

mFOLFIRINOX

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICESP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Camila MD Motta, PHD

Role: primary

Other Identifiers

NP 1950

Identifier Type: -

Identifier Source: org_study_id