Study on Liposomal Irinotecan, TAS102, and Bevacizumab for Patients with Advanced Colorectal Cancer

Sponsor: University of Wisconsin, Madison

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05854498

Provider View

This clinical trial is exploring whether a combination of liposomal irinotecan, TAS102, and bevacizumab can benefit patients with advanced colorectal cancer that has not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new combination of drugs—liposomal irinotecan, TAS102, and bevacizumab—can help patients with advanced colorectal cancer that has not responded to standard treatments. The trial will take place at the UW Carbone Cancer Center and will involve 25 participants over a period of three years. Researchers aim to see if this combination can slow down the progression of the cancer and evaluate its safety and effectiveness.

Description

This study is a phase II trial focusing on patients with advanced colorectal cancer that cannot be removed by surgery and has not responded to previous treatments. The trial will test a combination of three drugs: liposomal irinotecan (nal-IRI), TAS102, and bevacizumab. Participants must have already been treated with certain chemotherapy drugs, including 5-fluorouracil, oxaliplatin, and irinotecan, and if their cancer is RAS wild-type, they must have received anti-EGFR therapy. The study will enroll 25 patients over 12 months, with the entire trial expected to last three years. The main goal is to see if this drug combination can extend the time patients live without their cancer getting worse. Researchers will also look at how well the cancer responds to the treatment and assess the safety of the drug combination.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a confirmed diagnosis of colorectal cancer that has spread or cannot be removed by surgery.
  • The cancer must be mismatch repair proficient.
  • Must have previously been treated with 5-fluorouracil, oxaliplatin, and irinotecan. If the cancer is RAS wild-type, must have received anti-EGFR therapy with cetuximab or panitumumab. If RAS wild-type and HER2 positive, must have had HER2 targeted therapy.

Exclusion Criteria

  • Cannot have uncontrolled medical conditions that would prevent completing the treatment.
  • Cannot have cancer with BRAF V600 mutations.
  • Must stop using certain medications that affect liver enzymes (CYP3A4) at least two weeks before starting the trial.
  • Cannot have cancers that are mismatch repair deficient or have high microsatellite instability.
  • Cannot have previously received TAS102.

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