A Phase I Trial Targeting Mitochondrial Metabolism With Papaverine in Combination With Chemoradiation for Stage II-III Non-Small Cell Lung Cancer
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the maximally tolerated dose of papaverine (PPV) in combination with chemoradiation (CRT)/radiation therapy (RT) in patients with unresectable locally advanced (LA) non-small cell lung cancer (NSCLC) or oligometastatic NSCLC. SECONDARY OBJECTIVES: I. To estimate the rates of primary tumor control, local control, time to local-regional progression, disease-free survival (DFS), and overall survival (OS). II. To assess whether blood oxygen level determination (BOLD) functional magnetic resonance imaging (MRI) studies can predict which patients may respond bes…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN * Creatinine \< 1.5 mg/dL or calculated creatinine clearance\* \>= 50 mL/min or 24-hour urine creatinine clearance \>= 50 mL/min * Calculated by the Cockcroft-Gaul…
Interventions
- DrugCarboplatin
Given IV
- BiologicalDurvalumab
Given IV
- DrugPaclitaxel
Given IV
- DrugPapaverine
Given IV or SC
- RadiationRadiation Therapy
Undergo RT
- DrugPemetrexed
Given IV
- RadiationHypofractionated Radiation Therapy
Undergo hypofractionated RT
Locations (2)
- City of HopeDuarte, California
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio