Pancreatic AdenocarcinomaPhase 1I-FLOATNCT04361708
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
A Phase 1 study testing Oxaliplatin, Docetaxel and Leucovorin in people with Pancreatic Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma
- What is being tested?
- Oxaliplatin, Docetaxel and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2020to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status =1
- Life expectancy > 3 months
- Adequate organ function, as defined by each of the following:
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- 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
- Measurable or non-measurable disease will be allowed.
- Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
- Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
- 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.
Who cannot join
- Prior radiation therapy for any cancer.
- Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- 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.
- Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0.
- Documented brain metastases
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- Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment.
- Active uncontrolled bleeding.
- Pregnancy or breastfeeding.
- Major surgery within 4 weeks.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Daniel Catenacci, MD
About this study
Official title: A Phase 1 Dose Finding Study of the gFOLFOXIRITAX Regimen Using UGT1A1 Genotype-directed Irinotecan With Fluorouracil, Leucovorin, Oxaliplatin and Taxotere in Patients With Untreated Advanced Upper Gastrointestinal Adenocarcinomas: The I-FLOAT Study
The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).
- Being tested
- Oxaliplatin, Docetaxel, Leucovorin, Irinotecan, 5-Fluorouracil
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Oxaliplatin will be administered on day 1 of each cycle at 85mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
DocetaxelDrug
Docetaxel will be administered on day 1 of each cycle at 25mg at dose level 1; 37.5 at dose level 2. The drugs will be given through the patient's Mediport.It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
LeucovorinDrug
Leucovorin will be administered on day 1 of each cycle at 400mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
IrinotecanDrug
Irinotecan will be administered on day 1 of each cycle at 120mg/m2 for low risk group, 105mg/m2 for intermediate risk group, 45mg/m2 for high risk group . The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
5-FluorouracilDrug
5-FU is given as a continuous intravenous infusion over 2 days. Patient can receive the 2-day infusion as an outpatient. On day 3 of each cycle, the patient will return to the infusion center to have the infusion hook-up disconnected.
| Study group | Role | What they receive |
|---|---|---|
| High Risk UGT1A1 genotype | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Docetaxel; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil |
| Intermediate Risk UGT1A1 genotype | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Docetaxel; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil |
| Low Risk UGT1A1 genotype | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Docetaxel; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum dose tolerated
To determine the maximum tolerated dose in the first month of therapy in each of the three main genotype groups (low, intermediate, and high risk) using genotype-guided dosing of irinotecan as part of the I-FLOAT regimen
Measured: 1 month
Secondary outcomes (5)
Cumulative dose of each chemotherapy drug
To determine the cumulative dose of each chemotherapy drug (irinotecan, 5-FU, oxaliplatin, docetaxel) administered in each genotype group over a period of 4 months (8 doses).
Measured: 4 months
Total duration of therapy
To determine the total duration of therapy, which would be administered perioperatively in future studies for the curative-intent setting.
Measured: 18 months
Overall Response Rate
To determine early efficacy (overall responsive rate, progression free survival, and overall survival) in all patients enrolled and treated in the study.
Measured: 5 years
Progression free survival rate
To determine early efficacy (overall responsive rate, progression free survival, and overall survival) in all patients enrolled and treated in the study.
Measured: 5 years
Overall survival rate
To determine early efficacy (overall responsive rate, progression free survival, and overall survival) in all patients enrolled and treated in the study.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start8 May 2020
- Primary completionJun 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Catenacci, MD, Principal investigator, University of Chicago Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361708
- Sponsor's protocol ID
- IRB19-1292
- Acronym
- I-FLOAT
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Finding Study of the gFOLFOXIRITAX Regimen Using UGT1A1 Genotype-directed Irinotecan With Fluorouracil, Leucovorin, Oxaliplatin and Taxotere in Patients With Untreated Advanced Upper Gastrointestinal Adenocarcinomas: The I-FLOAT Study
- ClinicalTrials.gov ID
- NCT04361708
- Acronym / sponsor ID
- I-FLOAT / IRB19-1292
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Risk UGT1A1 genotype | Experimental | Drug: Oxaliplatin, Drug: Docetaxel, Drug: Leucovorin, Drug: Irinotecan, Drug: 5-Fluorouracil |
| Intermediate Risk UGT1A1 genotype | Experimental | Drug: Oxaliplatin, Drug: Docetaxel, Drug: Leucovorin, Drug: Irinotecan, Drug: 5-Fluorouracil |
| Low Risk UGT1A1 genotype | Experimental | Drug: Oxaliplatin, Drug: Docetaxel, Drug: Leucovorin, Drug: Irinotecan, Drug: 5-Fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status =1
- Life expectancy > 3 months
Key exclusion criteria (11 listed)
- Prior radiation therapy for any cancer.
- Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- 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.
- Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinOxaliplatin will be administered on day 1 of each cycle at 85mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months) | Drug | High Risk UGT1A1 genotype, Intermediate Risk UGT1A1 genotype, Low Risk UGT1A1 genotype |
| DocetaxelDocetaxel will be administered on day 1 of each cycle at 25mg at dose level 1; 37.5 at dose level 2. The drugs will be given through the patient's Mediport.It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months) | Drug | High Risk UGT1A1 genotype, Intermediate Risk UGT1A1 genotype, Low Risk UGT1A1 genotype |
| LeucovorinLeucovorin will be administered on day 1 of each cycle at 400mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months) | Drug | High Risk UGT1A1 genotype, Intermediate Risk UGT1A1 genotype, Low Risk UGT1A1 genotype |
| IrinotecanIrinotecan will be administered on day 1 of each cycle at 120mg/m2 for low risk group, 105mg/m2 for intermediate risk group, 45mg/m2 for high risk group . The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months) | Drug | High Risk UGT1A1 genotype, Intermediate Risk UGT1A1 genotype, Low Risk UGT1A1 genotype |
| 5-Fluorouracil5-FU is given as a continuous intravenous infusion over 2 days. Patient can receive the 2-day infusion as an outpatient. On day 3 of each cycle, the patient will return to the infusion center to have the infusion hook-up disconnected. | Drug | High Risk UGT1A1 genotype, Intermediate Risk UGT1A1 genotype, Low Risk UGT1A1 genotype |
Primary outcome
The maximum dose tolerated
Time frame: 1 month
To determine the maximum tolerated dose in the first month of therapy in each of the three main genotype groups (low, intermediate, and high risk) using genotype-guided dosing of irinotecan as part of the I-FLOAT regimen
5 secondary outcomes
Cumulative dose of each chemotherapy drug
Time frame: 4 months
Total duration of therapy
Time frame: 18 months
Overall Response Rate
Time frame: 5 years
Progression free survival rate
Time frame: 5 years
Overall survival rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Catenacci, MD principal investigator
University of Chicago Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxaliplatin, Docetaxel and Leucovorin in people with Pancreatic Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Catenacci, MD (773-702-7596, dcatenacci@medicine.bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum dose tolerated (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.