Health Trials

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

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

Treatments tested in this trial

  • Carboplatin
  • Durvalumab
  • Paclitaxel
  • Papaverine
  • Radiation Therapy
  • Pemetrexed
  • Hypofractionated Radiation Therapy
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Computed Tomography
  • Magnetic Resonance Imaging of the Brain with and without Contrast
  • Biospecimen Collection

Treatment groups

28 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov