Combining liposomal irinotecan, TAS102, and bevacizumab for advanced colorectal cancer
Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
This study is testing a new combination of three cancer drugs to see if it can help people with advanced colorectal cancer that hasn’t improved with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | cetuximab, panitumumab, bevacizumab |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05854498 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic or unresectable colorectal adenocarcinoma that is mismatch repair proficient and has previously been treated with standard therapies.
Not a fit: Patients with BRAF V600 mutations or those with mismatch repair deficient cancers will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with treatment-resistant metastatic colorectal cancer.
How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in treating metastatic colorectal cancer with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madison, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.