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Trial Title:
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
NCT ID:
NCT05854498
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal irinotecan
Description:
50mg/m2 IV on days 1 and 15
Arm group label:
Participants with Metastatic or Unresectable Colorectal Cancer
Intervention type:
Drug
Intervention name:
TAS102
Description:
35mg/m2 PO BID on days 1-5 and 15-19
Arm group label:
Participants with Metastatic or Unresectable Colorectal Cancer
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
5mg/kg IV on days 1 and 15
Arm group label:
Participants with Metastatic or Unresectable 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.
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Wisconsin Carbone Cancer Center
Address:
City:
Madison
Zip:
52792
Country:
United States
Status:
Recruiting
Start date:
October 13, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Collaborator:
Agency:
Ipsen
Agency class:
Industry
Source:
University of Wisconsin, Madison
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05854498
