Genetic cheat code may unlock safer, stronger chemo cocktail for tough cancers
NCT ID NCT04361708
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a powerful mix of five chemotherapy drugs for people with advanced upper gastrointestinal cancers, including pancreatic and stomach cancers. The study uses each person's genetic profile to adjust the dose of one of the drugs (irinotecan) to try to reduce side effects. The main goal is to find the safest dose, not yet to prove the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of five chemotherapy drugs: irinotecan, fluorouracil (5-FU), leucovorin, oxaliplatin, and docetaxel
- What this could lead to
- If successful, this could lead to a more effective chemotherapy regimen for advanced upper gastrointestinal cancers, tailored to a patient's genetic profile.
- What could go wrong
- This is an early Phase 1 trial with only 54 participants, focused on finding safe doses, not proving the treatment works. The combination of five strong chemotherapies may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2020
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastroesophageal adenocarcinoma, cholangiocarcinoma, gallbladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with upper GI primary suspected), or other primary GI malignancy for which the treating physician feels that I-FLOAT is a reasonable therapeutic option. 2. Patients with a history of obstructive jaundice due to the primary tumor must have resolved to \<1.5 X upper limit of normal and a metal biliary stent in place 3. Age greater than or equal to 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status =1 5. Life expectancy \> 3 months 6. Adequate organ function, as defined by each of the following: Absolute neutrophil count (ANC) = 1500/uL Hemoglobin \> 9g/dL (transfusion permitted with stability for \> 1 week) Platelets \> 100,000/uL Total bilirubin = 1.5 mg/dL AST and ALT = 2.5 X upper limit of normal; alkaline phosphatase = 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis. AST and ALT = 5 X upper limit of normal if hepatic metastases are present. Creatinine = 1.5 mg/dL 7. Measurable or non-measurable disease will be allowed. 8. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. 9. Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential 10. Patients taking substrates, inhibitors, or inducers of CYP3A4 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan. Exclusion Criteria: 1. Prior radiation therapy for any cancer. 2. Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met 3. Inflammatory bowel disease (Crohn's disease, ulcerative colitis) 4. Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v. 4.0\*). Pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement. 5. Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0. 6. Documented brain metastases 7. Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment. 8. Active uncontrolled bleeding. 9. Pregnancy or breastfeeding. 10. Major surgery within 4 weeks. 11. Previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%, and meets all other eligibility criteria.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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