RecruitingPhase 2NCT05854498

Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Sponsor

University of Wisconsin, Madison

Enrollment

50 participants

Start Date

Oct 13, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer

Summary

This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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.

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