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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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