Clinical trial NCT05854498: Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
Official title: Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2023-05-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a nonrandomized, single arm, open-label study of the combination of liposomal irinotecan with TAS102 and bevacizumab in patients with treatment refractory metastatic colorectal cancer.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This prospective phase II, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-IRI), TAS102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if RAS wild-type an anti-EGFR agent. A total of 25 patients will be accrued at UW Carbone Cancer Center. Subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years.

Primary Objective

* To determine the progression free survival (PFS) of patients with metastatic colorectal cancer treated in the treatment refractory setting with liposomal irinotecan in combination with TAS102 and bevacizumab.

Secondary Objectives

* To evaluate the objective response rate (ORR) of liposomal irinotecan in combination with bevacizumab and TAS102.
* To assess the safety and tolerability of these regimens in this setting.
* To determine the impact of the timing of irinotecan use in prior lines of therapy on the ORR and PFS observed with these nal-IRI containing treatment regimens

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 2 years
measure: Number of Participants Experiencing Grade 3 and 4 Toxicities
timeFrame: up to 30 days post-treatment (approximately 6 months on study)
measure: Summary of Grade 3 and 4 Toxicities by Count of participants
timeFrame: up to 30 days post-treatment (approximately 6 months on study)
measure: Efficacy of irinotecan measured by PFS for patients with and without irinotecan containing regimens
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: UW Carbone Cancer Center
name: Dustin Deming, MD
role: PRINCIPAL_INVESTIGATOR
References: