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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Daniel Catenacci, MD · PRINCIPAL_INVESTIGATOR · University of Chicago Medicine
Who to contact
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What this trial measures
- 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