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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 from entry on the study until the time of any documented disease recurrence or death, assessed at 12 and 24 months post-treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 and 24 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 and 24 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 and 24 months post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT)

Secondary study objectives

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

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: 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

Durvalumab

2017

Completed Phase 2

~3750

Radiation Therapy

2017

Completed Phase 3

~7250