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Trial Title:
In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung
NCT ID:
NCT05611034
Condition:
Lung Metastases
Colorectal Cancer Metastatic
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Oxaliplatin
Conditions: Keywords:
IVLP
metastatic
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin infusion in single lung via IVLP technique
Arm group label:
IVLP in single lung
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis of Colorectal Carcinoma
2. Presence of bilateral pulmonary metastases
3. 3 or more lung lesions in total
4. Age 70 years or less
5. ECOG 0-2
6. Absence of extra-pulmonary disease, except liver metastases suitable to curative
treatment.
Exclusion Criteria:
1. Patient has previously received more than 1000 mg of oxaliplatin
2. Left Ventricular Ejection Fraction <50%
3. History of significant pulmonary disease or pneumonitis
4. Pregnant or lactating females
5. Age 71 or older, or less than 18 years
6. Inability to understand the informed consent process
7. Hypersenstivity to oxaliplatin
8. Patients with Heparin-induced thrombocytopenia (HIT)
9. Patients who cannot receive cefazolin or methylprednisolone due to allergy or
another reason can be included but will not receive the drug they cannot tolerate
10. Current participation in another therapeutic clinical trial
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Health Network, Toronto General Hospital
Address:
City:
Toronto
Zip:
M5G 2C4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jennifer Lister, BSc CCRP
Phone:
416-340-4857
Email:
Jennifer.Lister@uhn.ca
Investigator:
Last name:
Marcelo Cypel, MD
Email:
Principal Investigator
Start date:
February 6, 2023
Completion date:
January 1, 2032
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05611034
