A Phase 1 interventional study of Oxaliplatin in Lung Metastases, Colorectal Cancer Metastatic and Colorectal Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University Health Network, Toronto · Phase 1, Interventional, and Treatment
This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.
Exclusion Criteria:
Drug: Oxaliplatin
Oxaliplatin infusion in single lung via IVLP technique
safety as measured by acute lung injury findings
Chest x- ray findings of pulmonary edema in the perfused lung in the first 72 hours (Grade 0-5).
Time frame: 72 hours
recurrence patterns
Time frame: 5 years
Incidence of pneumonia after procedure
Time frame: 72 hours
Incidence of ICU admission
Time frame: 72 hours
Incidence of mechanical ventilation
Time frame: 72 hours
Plan to share: No
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University Health Network, Toronto