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

Instituto do Cancer do Estado de São Paulo

Status and phase

Unknown

Phase 2

Conditions

Colorectal Cancer Stage IV

Treatments

Drug: mFOLFIRINOX

Study type

Interventional

Funder types

Other

Identifiers

NCT05354817

NP 1950

Details and patient eligibility

About

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.

Full 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

Enrollment

25 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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