Safety of Combining Irinotecan with Other Chemotherapies for Adenocarcinoma

This study is looking at the safety of combining several chemotherapy drugs: irinotecan, 5-fluorouracil (5-FU), leucovorin (a vitamin that helps 5-FU work), oxaliplatin, and docetaxel. This combination is called I-FLOAT. The study aims to find the highest safe dose of these drugs when given together. You may be able to join if you are 18 or older and have certain types of adenocarcinoma, including pancreatic, gastroesophageal junction, or other related cancers. The study plans to enroll 54 participants. The main goal is to determine the maximum tolerated dose within one month.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is designed to find the safest dose of the drug combination.
What's involved
You will receive treatments through a Mediport every 14 days for about 4 months. One of the drugs, 5-FU, is given as a continuous infusion over two days, and you will return to the clinic on day 3 to have it disconnected.
Compensation
Not stated in the trial record.
Follow-up
The primary safety outcome is measured at 1 month, but the treatment period is planned for 4 months.

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NCT04361708

Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Chicago
~54 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:OxaliplatinDocetaxelLeucovorinIrinotecan5-Fluorouracil

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The maximum dose tolerated
Measured over 1 month
Pancreatic Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Adenocarcinoma
1 sites across 1 states
Illinois1
  • Daniel Catenacci, MD · PRINCIPAL_INVESTIGATOR · University of Chicago Medicine

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  • The maximum dose tolerated1 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