mFOLFIRINOX for Stomach Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Chicago
Must not be taking: CYP3A4 substrates
Disqualifiers: Previous malignancy, Inflammatory bowel disease, Diarrhea, Neuropathy, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This pilot clinical trial studies genetic analysis-guided irontecan hydrochloride dosing of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin (mFOLFIRINOX) in treating patients with gastroesophageal or stomach cancer that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin calcium may also help fluorouracil work better. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.
Will I have to stop taking my current medications?
The trial suggests that if you are taking medications that affect a specific liver enzyme (CYP3A4), you should try to switch to other drugs to avoid interactions with the trial medication. It doesn't specify a need to stop other medications, but it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug mFOLFIRINOX for stomach cancer?
Research shows that a similar drug combination, mFOLFIRI, which includes some of the same components as mFOLFIRINOX, has been effective as a second-line treatment for advanced gastric (stomach) cancer, especially after other treatments have failed.
12345Is mFOLFIRINOX safe for humans?
The mFOLFIRINOX treatment, which includes 5-fluorouracil, irinotecan, and oxaliplatin, has been used in advanced pancreatic cancer and is known to have some side effects, but it is generally considered safe for fit patients. It has been evaluated for safety in other cancers, like gastric and colorectal cancer, showing it can be tolerated with careful monitoring.
12467What makes the mFOLFIRINOX drug unique for stomach cancer?
The mFOLFIRINOX drug is unique for stomach cancer because it combines four different chemotherapy agents (fluorouracil, leucovorin, irinotecan, and oxaliplatin) that work together to target cancer cells more effectively. This combination is adapted from its use as a first-line treatment in advanced pancreatic cancer, offering a novel approach for stomach cancer where standard treatments may not be well-established.
12389Eligibility Criteria
This trial is for adults with advanced gastroesophageal or stomach cancer without distant spread. They must be fit for surgery, have certain blood counts and organ functions within set limits, not be pregnant, agree to use birth control, and can't have other cancers or serious illnesses that could interfere with the study.Inclusion Criteria
My cancer is a type of stomach or esophagus cancer confirmed by tissue analysis.
I am a candidate for surgery aimed at curing my condition.
Specific blood count requirements (ANC, Hemoglobin, Platelets)
+9 more
Exclusion Criteria
I have moderate to severe nerve damage.
Pregnancy or breastfeeding
Serious underlying medical or psychiatric illnesses
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Preoperative Therapy
Patients receive oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and fluorouracil intravenously. Courses repeat every 2 weeks for 4 courses.
8 weeks
Surgery
Patients undergo conventional surgery.
Post-operative Therapy
Beginning 5-10 weeks after surgery, patients receive oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and fluorouracil intravenously. Courses repeat every 2 weeks for 4 more courses.
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment.
5 years
Every 3 months for 2 years, then every 6 months for 3 years
Participant Groups
The trial tests a personalized dose of Irinotecan in the mFOLFIRINOX regimen (a combination of chemotherapy drugs) based on genetic analysis. The goal is to see if tailoring the dose improves tolerance and effectiveness against locally advanced gastroesophageal or stomach cancer.
1Treatment groups
Experimental Treatment
Group I: Treatment (mFOLFIRINOX, surgery)Experimental Treatment5 Interventions
PREOPERATIVE THERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo conventional surgery.
POST-OPERATIVE THERAPY: Beginning 5-10 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 more courses in the absence of disease progression or unacceptable toxicity.
Fluorouracil is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as 5-Fluorouracil for:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Skin cancer
🇪🇺 Approved in European Union as 5-Fluorouracil for:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
🇨🇦 Approved in Canada as 5-Fluorouracil for:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NorthShore University HealthSystemEvanston, IL
University of Chicago Comprehensive Cancer CenterChicago, IL
Kellogg Cancer Center - Evanston HospitalEvanston, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Modified 5-fluorouracil/leucovorin/irinotecan as a feasible and efficacious second-line chemotherapeutic regimen in advanced gastric cancers. [2022]Modified 5-fluorouracil/leucovorin/irinotecan (mFOLFIRI) is a commonly used combination second-line chemotherapeutic regimen in advanced gastric cancer (AGC).
Modified FOLFIRI as Second-Line Chemotherapy after Failure of Modified FOLFOX-4 in Advanced Gastric Cancer. [2021]The purpose of this study was to evaluate efficacy and toxicity of irinotecan, leucovorin and 5-fluorouracil (FOLFIRI) as second-line treatment after failure of oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX) for advanced gastric cancer.
A randomized phase II study of biweekly irinotecan monotherapy or a combination of irinotecan plus 5-fluorouracil/leucovorin (mFOLFIRI) in patients with metastatic gastric adenocarcinoma refractory to or progressive after first-line chemotherapy. [2022]The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC).
Irinotecan combined with 5-fluorouracil and leucovorin third-line chemotherapy after failure of fluoropyrimidine, platinum, and taxane in gastric cancer: treatment outcomes and a prognostic model to predict survival. [2022]The aim of this study was to evaluate the activity and safety of the combination chemotherapy of 5-fluorouracil (5-FU), leucovorin, and irinotecan (FOLFIRI regimen) after failure of fluoropyrimidine, platinum, and taxane in gastric cancer (GC) and to evaluate the prognostic factors for survival.
A phase II study of irinotecan with biweekly, low dose leucovorin and bolus and continuous infusion 5-fluorouracil (modified FOLFIRI) as first line therapy for patients with recurrent or metastatic gastric cancer. [2018]To determine the activity and toxicities of a low-dose leucovorin plus 5-fluorouracil (5-FU) regimen, combined with irinotecan and administered every 2 weeks (modified FOLFIRI), as a first-line therapy for patients with advanced gastric cancer.
AMALTHEA: Prospective, Single-Arm Study of the Hellenic Cooperative Oncology Group (HeCOG) Evaluating Efficacy and Safety of First-Line FOLFIRI + Aflibercept for 6 Months Followed by Aflibercept Maintenance in Patients With Metastatic Colorectal Cancer. [2019]The efficacy and safety of the FOLFIRI (leucovorin, 5-fluorouracil, irinotecan, and oxaliplatin) regimen combined with aflibercept has not been studied in the first-line management of patients with metastatic colorectal cancer (mCRC).
Safety and Efficacy of Modified FOLFIRINOX for Advanced Pancreatic Adenocarcinoma: A UK Single-Centre Experience. [2023]The combination of 5-fluorouracil (5-FU), irinotecan and oxaliplatin (FOLFIRINOX) is considered the first-line chemotherapy for fit patients with advanced pancreatic ductal adenocarcinoma (PDAC) but carries an unfavourable adverse event (AE) profile. We retrospectively evaluated the tolerability and efficacy of a modified FOLFIRINOX (mFOLFIRINOX) regimen: intravenous oxaliplatin 85 mg/m2, irinotecan 135 mg/m2, folinic acid 400 mg/m2 and 5-FU infusion 2,400 mg/m2 over 46 h, with routine subcutaneous filgrastim on a 14-day cycle.
A phase I/II study of arfolitixorin and 5-fluorouracil in combination with oxaliplatin (plus or minus bevacizumab) or irinotecan in metastatic colorectal cancer. [2022]5-fluorouracil (5-FU) combined with a folate remains an essential treatment component for metastatic colorectal cancer (mCRC). Leucovorin is the folate most often used, but requires intracellular conversion to a reduced folate, and has high pharmacokinetic variability and limited bioavailability in patients with low folate pathway gene expression. Arfolitixorin is an immediately active form of folate, [6R]-5,10-methylenetetrahydrofolate ([6R]-MTHF), and may improve outcomes.
Efficacy and safety of SOXIRI versus mFOLFIRINOX in advanced pancreatic cancer. [2023]Modified fluorouracil/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) regimen (mFOLFIRINOX), comprised of fluorouracil, leucovorin, irinotecan and oxaliplatin, is the first-line standard chemotherapy in patients with advanced pancreatic cancer. The S-1/oxaliplatin/irinotecan (SOXIRI) regimen has also been studied recently under similar conditions. This study compared its efficacy and safety.