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Platinum-based Chemotherapy

Papaverine + Chemoradiation for Lung Cancer

Phase 1
Recruiting
Led By Jeremey Brownstein, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 18 years old
Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven
Must not have
Hepatic insufficiency resulting in jaundice and/or coagulation defects
History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and 24 months post-treatment
Awards & highlights

Summary

This trial is testing whether papaverine, which targets mitochondrial metabolism, can decrease cancer growth when given with chemoradiation to patients with stage II-III non-small cell lung cancer.

Who is the study for?
Adults with stage II-III non-small cell lung cancer that hasn't spread beyond the original site and is considered inoperable. Participants must have a life expectancy over 6 months, be well enough for chemotherapy with radiation, and not have had certain other cancers or treatments within specific time frames. They should also not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of papaverine combined with chemoradiation therapy (using carboplatin and paclitaxel) on patients with non-small cell lung cancer. Papaverine aims to slow down cancer growth by targeting mitochondrial metabolism.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, blood count changes, potential organ inflammation due to papaverine, as well as skin reactions from radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My lung cancer is confirmed to be non-small cell type.
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My lung cancer is at stage II-III, according to the AJCC.
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All my previous treatment side effects are mild, except for hair loss.
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I can undergo standard chemotherapy with radiation (carboplatin + paclitaxel).
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My condition cannot be treated with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have liver problems causing yellowing of my skin or eyes and issues with blood clotting.
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I have a history of scleroderma or idiopathic pulmonary fibrosis.
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I do not have AIDS as defined by the CDC.
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I have had radiation therapy before in the same area.
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I haven't been hospitalized for lung problems in the last 30 days.
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I do not have severe uncontrolled nerve pain or damage.
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I had a major heart attack in the last 6 months.
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I have had a lung removed in the past.
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My liver is not working well, causing jaundice or blood clotting issues.
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My cancer has spread to other parts of my body.
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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.
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I have cancerous nodules in the opposite lobe of my lung.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry until the time of death from any cause, assessed at 12 and 24 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry until the time of death from any cause, assessed at 12 and 24 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT)
Secondary outcome measures
Changes in blood-based biomarkers related to predict patients response to PPV + CRT
Changes in magnetic resonance imaging (MRI) blood oxygen level dependent (BOLD) response on MRI
Changes in tissue-based biomarkers related to predict patients response to PPV + CRT
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (papaverine, RT, paclitaxel, carboplatin)Experimental Treatment6 Interventions
Patients receive PPV IV or SC and undergo 5 fractions of RT per week. Patients also receive paclitaxel IV over 1 hour and carboplatin IV QW over 1-6 weeks or pemetrexed IV over 10 minutes followed by carboplatin IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 month of completing CRT, patients with PD-L1 positive disease receive durvalumab IV Q2W for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Papaverine
2019
Completed Phase 4
~310
Radiation Therapy
2017
Completed Phase 3
~7250
Carboplatin
2014
Completed Phase 3
~6670
Durvalumab
2017
Completed Phase 2
~3840
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
290,576 Total Patients Enrolled
Jeremey Brownstein, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05136846 — Phase 1
~4 spots leftby Dec 2024
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