Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Ir… (NCT05354817) | Clinical Trial Compass
UnknownPhase 2
Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin
Brazil25 participantsStarted 2021-10-22
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
What they're measuring
1
Assess response rate after 4 cycles of FOLFIRINOX
Timeframe: 2 years
Trial details
NCT IDNCT05354817
SponsorInstituto do Cancer do Estado de São Paulo