In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung

Colorectal Cancer Clinical Trial

Official title:

In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611034
• Other study ID #: 20-6152
• Status: Recruiting
• Phase: Phase 1
• Start date: February 6, 2023
• Est. completion date: January 1, 2032

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: Jennifer K Lister
• Phone: 416-340-4857
• Email: jennifer.lister[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2032
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Lung Metastases
• Neoplasm Metastasis

Intervention

Drug:
• Oxaliplatin
Oxaliplatin infusion in single lung via IVLP technique

Locations

Country	Name	City	State
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	72 hours
Secondary	recurrence patterns		5 years
Secondary	Incidence of pneumonia after procedure		72 hours
Secondary	Incidence of ICU admission		72 hours
Secondary	Incidence of mechanical ventilation		72 hours