Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorect… (NCT03290937) | Clinical Trial Compass
CompletedPhase 1
Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer
United States34 participantsStarted 2017-12-27
Plain-language summary
This phase I trial studies the best dose and side effects of irinotecan hydrochloride when given with utomilumab and cetuximab in treating patients with colorectal cancer that has spread to other places in the body (metastatic). Monoclonal antibodies, such as utomilumab and cetuximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving utomilumab, cetuximab, and irinotecan hydrochloride may work better in treating patients with colorectal cancer.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically and or cytologically confirmed metastatic colorectal cancer
* Patients must have a wild type or mutated RAS tumor status known prior to enrollment
* Metastatic colorectal cancer patients have progressed following at least one line of fluorouracil (5-FU)-based chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patients must have measurable disease per irRECIST criteria for part 2 (dose expansion)
* Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L (1,000/uL)
* Platelet count \>= 75 x 10\^9/L (75000/L)
* Hemoglobin \>= 8.0 g/dL (\>= 5.0 mmol/L)
* Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to screening)
* Serum creatinine \< 2 x upper limit of normal (ULN) or estimated creatinine clearance \> 30 ml/min as calculated using the method standard for the institution
* Total serum bilirubin \< 1.5 x ULN, unless the patient has documented Gilbert syndrome
* Aspartate and Alanine Aminotransferase (AST and ALT) \< 3 x ULN
* Left ventricular ejection fraction (LVEF) that is greater than 40%, or the absence of New York Heart Association (NYHA) classification of greater than stage II congestive heart failure
* Resolved acute effects of any prior therapy to baseline severity or grade =\< 2 Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 except for adverse events (AEs) not constituting a safety risk by …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended phase 2 dose of irinotecan hydrochloride (Dose escalation)