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Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer

ConditionsLocally Advanced Lung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Unresectable Lung Non-Small Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This phase I trial finds out the best dose, possible benefits and/or side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =< grade 1 (except alopecia) at the time of enrollment

Absolute neutrophil count >=1.5 x 10^9/L

Hemoglobin >= 9 g/dL

Platelets >= 100 x 10^9/L

Disqualifiers

Patients with history of pneumonectomy

History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis

History of previous radiation therapy which would result in overlapping radiation fields

Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Trial design

Design model

Single group

Treatments tested in this trial

  • Carboplatin

    Drug

    Given IV

  • Durvalumab

    Biological/Vaccine

    Given IV

  • Paclitaxel

    Drug

    Given IV

  • Papaverine

    Drug

    Given IV or SC

  • Radiation Therapy

    Radiation

    Undergo RT

  • Pemetrexed

    Drug

    Given IV

  • Hypofractionated Radiation Therapy

    Radiation

    Undergo hypofractionated RT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT or CT

  • Magnetic Resonance Imaging of the Brain with and without Contrast

    Procedure/Surgery

    Undergo brain MRI

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Treatment (papaverine, RT, paclitaxel, carboplatin)Experimental treatment 12 interventions

Trial outcomes

Primary outcomes

1

Maximally tolerated dose (MTD) of papaverine (PPV) in combination with chemoradiation treatment (CRT) or definitive hypofractionated radiation therapy

Will employ the Time-to-event Bayesian optimal interval design to find the MTD. Treatment-related toxicity will be assessed based on Common Terminology Criteria for Adverse Events version 5.0 criteria.

Time frame
6 weeks

Secondary outcomes

1

Primary tumor control rate

Defined as the absence of primary tumor failure. Will be calculated and 95% exact binomial confidence interval will be provided.

Time frame
At 12 and 24 months post-treatment
2

Local control rate

Defined as the absence of local failure, which is a combination of primary tumor and involved lobe failure. Will be calculated and 95% exact binomial confidence interval will be provided.

Time frame
At 12 and 24 months post-treatment
3

Time to local-regional progression

Will be summarized using Kaplan-Meier method.

Time frame
From entry on the study until the time of documented local-regional recurrence or death, assessed at 12 and 24 months post-treatment
4

Disease-free survival

Will be summarized using Kaplan-Meier method.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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