Combining liposomal irinotecan, TAS102, and bevacizumab for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, single-arm trial aims to evaluate the effectiveness of a combination treatment involving liposomal irinotecan, TAS102, and bevacizumab in patients with metastatic colorectal cancer that has not responded to previous therapies. The study will enroll 25 patients at the UW Carbone Cancer Center over a 12-month period, with a total duration of three years. The primary goal is to assess progression-free survival, while secondary objectives include evaluating the objective response rate and the safety of the treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1.
* Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.
* The cancer must be mismatch repair proficient.
* Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy.

Exclusion Criteria:

* Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy.
* Patients whose cancers possess BRAF V600 mutations are excluded.
* Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy.
* Patients must not have mismatch repair deficient or microsatellite instability high cancers.
* Patients must not have received prior TAS102.

Where it's running

• University of Wisconsin Carbone Cancer Center
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Dustin Deming, MD — UW Carbone Cancer Center
• Study coordinator: Cancer Connect
• Email: clinicaltrials@cancer.wisc.edu
• Phone: 800-622-8922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.