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Chemotherapy

Chemotherapy for Lung Cancer

Phase 1
Recruiting
Led By Marcelo 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
Age less than 65 years
3 or more lung lesions in total
Must not have
Patient has previously received more than 450 mg of doxorubicin
Previous lung metastatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new technique for delivering chemotherapy directly into the lungs at the time of surgery. The goal is to 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.

Who is the study for?
This trial is for people under 65 with sarcoma that has spread to both lungs, where one lung can be treated with surgery or radiation. They must have at least three lung lesions and no cancer outside the lungs. Patients should be relatively fit (ECOG 0-2) and not have had a lot of doxorubicin before.
What is being tested?
The study tests In Vivo Lung Perfusion (IVLP), a technique delivering chemotherapy directly into the lungs during surgery, aiming to kill unseen cancer cells while reducing harm to other organs. One lung gets IVLP; the other is treated normally as a control.
What are the potential side effects?
While IVLP aims to reduce side effects by targeting only the lungs, potential risks may include typical chemotherapy side effects like heart damage, immune system suppression, nausea, hair loss, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 65 years old.
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I have three or more spots on my lungs.
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I can take care of myself and am up and about more than half of the day.
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My cancer has spread to both lungs.
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My cancer on the opposite side can be treated with surgery or radiation.
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I have been diagnosed with soft tissue or bone cancer.
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My cancer has not spread beyond my lungs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received over 450 mg of doxorubicin.
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I have had surgery to remove lung metastases.
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I have a history of serious lung disease or inflammation.
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I am either 65 years or older, or younger than 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Doxorubicin 9 mcg/mlExperimental Treatment1 Intervention
Doxorubicin 9mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases
Group II: Doxorubicin 7 mcg/ml - expansionExperimental Treatment1 Intervention
Expansion group at ideal dose
Group III: Doxorubicin 7 mcg/mlExperimental Treatment1 Intervention
Doxorubicin 7mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases
Group IV: Doxorubicin 5 mcg/mlExperimental Treatment1 Intervention
Doxorubicin 5mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~8030

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,305 Total Patients Enrolled
Marcelo Cypel, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Doxorubicin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02811523 — Phase 1
Soft Tissue Sarcoma Research Study Groups: Doxorubicin 5 mcg/ml, Doxorubicin 7 mcg/ml, Doxorubicin 9 mcg/ml, Doxorubicin 7 mcg/ml - expansion
Soft Tissue Sarcoma Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT02811523 — Phase 1
Doxorubicin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02811523 — Phase 1
~0 spots leftby Feb 2025
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