Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposomal irinotecan, TAS102, Bevacizumab.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
Overview
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
Interventions
- Drug Liposomal irinotecan
50mg/m2 IV on days 1 and 15 - Drug TAS102
35mg/m2 PO BID on days 1-5 and 15-19 - Drug Bevacizumab
5mg/kg IV on days 1 and 15
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: up to 2 years]
Secondary outcome measures (4)
- Objective Response Rate (ORR) [Time frame: up to 2 years]
- Number of Participants Experiencing Grade 3 and 4 Toxicities [Time frame: up to 30 days post-treatment (approximately 6 months on study)]
- Summary of Grade 3 and 4 Toxicities by Count of participants [Time frame: up to 30 days post-treatment (approximately 6 months on study)]
- Efficacy of irinotecan measured by PFS for patients with and without irinotecan containing regimens [Time frame: up to 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin Carbone Cancer Center — Madison
Identifiers
NCT: NCT05854498 · 2023-0449 · Protocol Version 12/6/2025 · UW23016 · SMPH/MEDICINE/HEM-ONC · NCI-2023-05190