Colorectal Cancer Stage IV
Conditions
Keywords
Colorectal Cancer
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
Interventions
DRUGmFOLFIRINOX
mFOLFIRINOX: - Oxaliplatin; Leucovorin; Irinotecan and 5-FU
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess response rate after 4 cycles of FOLFIRINOX | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | 2 years |
| Overall Survival | 2 years |
Countries
Brazil
Outcome results
None listed