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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether liposomal irinotecan, TAS102, and bevacizumab work together to help treat colorectal cancer. It is for adults whose colon or rectal cancer has spread or cannot be removed by surgery and has not responded to past treatments.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be 18 or older.
- You must be fully active or able to do light work, even if you cannot do hard physical activity.
- Tissue or cell tests must confirm colorectal adenocarcinoma, a cancer of the colon or rectum. It must have spread or be unable to be removed by surgery.
- Your cancer must have a working system for fixing certain DNA errors, called mismatch repair proficient.
- You must have had treatments containing 5-fluorouracil, oxaliplatin, and irinotecan.
- If your cancer has no RAS gene mutation, you must have had cetuximab or panitumumab.
- If your cancer has no RAS gene mutation and is HER2 positive, you must have had treatment targeting HER2, a protein that helps cancer grow.
Who can't join
- You cannot join if you have an uncontrolled illness that would keep you from finishing the planned treatment.
- You cannot join if your cancer has a BRAF V600 gene mutation.
- You must stop medicines that strongly change how the body uses CYP3A4, a protein that breaks down drugs, at least 2 weeks before starting treatment.
- You cannot join if your cancer has a faulty DNA repair system, called mismatch repair deficient, or many DNA errors, called microsatellite instability high.
- You cannot join if you have had TAS102 before.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
WI
- University of Wisconsin Carbone Cancer Center · Madison, WI 52792More trials in Madison