Back to resultsImpact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin (Re-Play)
Primary Purpose
Colorectal Cancer Stage IV
Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
mFOLFIRINOX
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Stage IV focused on measuring Colorectal Cancer
Eligibility 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
Sites / Locations
- ICESPRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
mFolfirinox
Arm Description
Outcomes
Primary Outcome Measures
Assess response rate after 4 cycles of FOLFIRINOX
Secondary Outcome Measures
Progression-free survival
Overall Survival
Full Information
NCT ID
NCT05354817
First Posted
April 25, 2022
Last Updated
April 28, 2022
Sponsor
Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05354817
Brief Title
Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin
Acronym
Re-Play
Official Title
Re-Play: Impact of FOLFIRINOX Chemotherapy in IV Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Stage IV
Keywords
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mFolfirinox
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
mFOLFIRINOX
Intervention Description
mFOLFIRINOX: - Oxaliplatin; Leucovorin; Irinotecan and 5-FU
Primary Outcome Measure Information:
Title
Assess response rate after 4 cycles of FOLFIRINOX
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2 years
Title
Overall Survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila MD Motta, PHD
Phone
55 11 38932000
Email
icesp.pesquisa.np@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Paulo MD Hoff, PHD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin
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