What side effects are associated with this type of intervention?

Common treatments for lung cancer, including those similar to In Vivo Lung Perfusion (IVLP) with Oxaliplatin, often involve chemotherapy agents like oxaliplatin. Known side effects of oxaliplatin include peripheral neuropathy, neutropenia, nausea, vomiting, and fatigue. When chemotherapy is delivered directly to the lungs, as in IVLP, the aim is to minimize systemic side effects while targeting lung-specific cancer cells. However, potential side effects may still include localized lung toxicity, such as inflammation or damage to lung tissue, and general chemotherapy-related side effects like fatigue and nausea.

What prior FDA approvals exist?

FDA approvals for lung cancer treatments have included various systemic therapies, such as pembrolizumab and cemiplimab, which are immune checkpoint inhibitors used in advanced non-small cell lung cancer (NSCLC). While direct delivery of chemotherapy to the lungs, like the In Vivo Lung Perfusion (IVLP) technique with oxaliplatin, is still under investigation, traditional systemic chemotherapy regimens, including combinations like carboplatin with paclitaxel or nab-paclitaxel, have been approved. These systemic treatments aim to target cancer cells throughout the body but can lead to significant side effects. The IVLP technique represents a novel approach to minimize systemic toxicity by delivering chemotherapy directly to the lungs, although it has not yet received FDA approval.

What other types of research exist?

Promising alternatives to IVLP with Oxaliplatin for lung cancer patients include: 1) Prolonged venous infusion of cisplatin combined with concurrent radiation therapy, which has shown high response and survival rates with moderate toxicity. 2) Combination therapies such as paclitaxel plus oxaliplatin, which have demonstrated safety and efficacy in pretreated advanced non-small cell lung cancer (NSCLC) patients. These alternatives offer targeted approaches to treatment while aiming to reduce systemic side effects.

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IVLP with Oxaliplatin for Colorectal Cancer Spread to Lungs

Phase 1

Recruiting

Led By Marcelo K Cypel, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method of delivering chemotherapy directly into the lungs during surgery to treat patients with colorectal cancer that has spread to the lungs. The goal is to kill cancer cells in the lung while minimizing side effects to other organs. The study will determine the safest dose of the chemotherapy drug oxaliplatin when delivered using this method.

Who is the study for?

This trial is for people under 71 with colorectal cancer that has spread to both lungs but not beyond, except possibly the liver. They should be relatively fit (ECOG 0-2) and have at least three lung lesions. It's not for those with a history of severe lung disease, heart issues, or who've had high doses of oxaliplatin before.

What is being tested?

The study tests a new method called IVLP where chemotherapy (oxaliplatin) is delivered directly into one lung during surgery to target cancer cells while minimizing harm to other organs. The dose starts low and increases until it causes serious but temporary side effects.

What are the potential side effects?

Side effects from oxaliplatin via IVLP can include reactions specific to the infused lung such as inflammation or damage, general chemotherapy-related issues like nausea, nerve sensitivity changes, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lung

Side effects data

From 2016 Phase 4 trial • 128 Patients • NCT01588990

68%

Nausea

63%

Neuropathy peripheral

63%

Fatigue

55%

Diarrhoea

40%

Constipation

31%

Abdominal pain

30%

Palmar-plantar erythrodysaesthesia syndrome

28%

Vomiting

25%

Neutropenia

24%

Mucosal inflammation

23%

Epistaxis

22%

Decreased appetite

20%

Alopecia

20%

Paraesthesia

20%

Insomnia

20%

Gastrooesophageal reflux disease

19%

Headache

18%

Hypertension

17%

Stomatitis

17%

Back pain

16%

Urinary tract infection

16%

Rash

16%

Dysgeusia

14%

Upper respiratory tract infection

14%

Pain in extremity

13%

Mouth ulceration

13%

Thrombocytopenia

13%

Arthralgia

12%

Anaemia

12%

Dysaesthesia

11%

Weight decreased

11%

Oedema peripheral

11%

Musculoskeletal pain

10%

Cough

10%

Dyspnoea

10%

Abdominal pain upper

10%

Dyspepsia

10%

Pulmonary embolism

10%

Dizziness

Dysphonia

Depression

Pyrexia

Anxiety

Fall

Proteinuria

Dry skin

Lethargy

Abdominal distension

Rectal haemorrhage

Toothache

Neck pain

Dehydration

Oropharyngeal pain

Rhinorrhoea

Non-cardiac chest pain

Hypoalbuminaemia

Nail disorder

Intestinal obstruction

Hypotension

Haemorrhoids

Oral candidiasis

Oral herpes

Hypokalaemia

Muscle spasms

Sepsis

Bronchitis

Gastroenteritis

Pneumonia

Lower respiratory tract infection

Small intestinal obstruction

Anal abscess

Flank pain

Renal failure acute

Confusional state

Febrile neutropenia

Angina pectoris

Enterovesical fistula

Procedural site reaction

Gastrointestinal perforation

Muscle abscess

Wound infection

Gastroenteritis viral

Infected dermal cyst

Pneumonia streptococcal

Lobar pneumonia

Inguinal hernia

Clostridium difficile colitis

Intestinal perforation

Infusion related reaction

Pharyngitis

Infective exacerbation of chronic obstructive airways disease

Anal fissure

Colitis

Ileus

Colonic obstruction

Large intestine perforation

Melaena

Neutropenic colitis

Cholecystitis acute

Urosepsis

Cerebrovascular accident

Hemiparesis

Syncope

Rectal perforation

Catheter site pain

Extravasation

Abscess limb

Radius fracture

Hypomagnesaemia

Hypophagia

Haematuria

Hydronephrosis

Urinary incontinence

Pleural effusion

Pleuritic pain

Musculoskeletal chest pain

Procedural pain

Laceration

Gastrointestinal haemorrhage

Large intestinal obstruction

Transient ischaemic attack

Acute psychosis

Pneumonia aspiration

Jugular vein thrombosis

Orthostatic hypotension

Thrombophlebitis superficial

Device related infection

Ear infection

Enterocolitis infectious

Eyelid infection

Gangrene

Pilonidal cyst

Gastritis

Visual impairment

Dysphagia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab: Phase A and Phase B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IVLP in single lungExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

2011

Completed Phase 4

~2890

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer, such as chemotherapy, work by targeting rapidly dividing cancer cells to inhibit their growth and induce cell death. Oxaliplatin, a platinum-based chemotherapy agent, forms cross-links in DNA, preventing replication and transcription, which leads to cancer cell apoptosis. The IVLP technique, which delivers oxaliplatin directly to the lungs, aims to target microscopic cancer cells more effectively while minimizing systemic side effects. This localized approach is crucial for lung cancer patients as it potentially enhances the efficacy of the treatment and reduces the overall toxicity, improving patient outcomes and quality of life.