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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Colorectal Carcinoma

Presence of bilateral pulmonary metastases

3 or more lung lesions in total

Age 70 years or less

Disqualifiers

Patient has previously received more than 1000 mg of oxaliplatin

Left Ventricular Ejection Fraction <50%

History of significant pulmonary disease or pneumonitis

Pregnant or lactating females

Trial design

Design model

Sequential

Treatments tested in this trial

  • Oxaliplatin

    Drug

    Oxaliplatin infusion in single lung via IVLP technique

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: IVLP in single lungExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

recurrence patterns

Time frame
5 years
2

Incidence of pneumonia after procedure

Time frame
72 hours
3

Incidence of ICU admission

Time frame
72 hours
4

Incidence of mechanical ventilation

Time frame
72 hours

Other outcomes

Sponsors and contacts

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