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

Sponsor

Instituto do Cancer do Estado de São Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05354817

Collaborator

(none)

Enrollment

Location

Arm

25.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Stage IV	Drug: mFOLFIRINOX	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 22, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: mFolfirinox	Drug: mFOLFIRINOX mFOLFIRINOX: - Oxaliplatin; Leucovorin; Irinotecan and 5-FU

Arm

Intervention/Treatment

Other: mFolfirinox

Drug: mFOLFIRINOX

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

Outcome Measures

Primary Outcome Measures

Assess response rate after 4 cycles of FOLFIRINOX [2 years]

Secondary Outcome Measures

Progression-free survival [2 years]
Overall Survival [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICESP	Sao Paulo	SP	Brazil	01246000

Sponsors and Collaborators

Instituto do Cancer do Estado de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto do Cancer do Estado de São Paulo

ClinicalTrials.gov Identifier:

NCT05354817

Other Study ID Numbers:

NP 1950

First Posted:

Apr 29, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Instituto do Cancer do Estado de São Paulo

Colorectal Cancer

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Apr 29, 2022