This phase I trial studies the side effects and best dose of papaverine (PPV) when given together with radiation therapy (RT) and tests how well it works in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). PPV is an enzyme inhibitor, and it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving PPV with RT may be safe, tolerable, and/or effective in treating patients with locally advanced rectal cancer.
Documented informed consent of the participant and/or legally authorized representative
Willingness to participate in all correlative studies: fMRI, and tissue collection of tumor and normal rectum (ribonucleic acid [RNA]/deoxyribonucleic acid [DNA]/protein), blood (plasma/peripheral blood mononuclear cell [PBMC]) draws and stool collection
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy
Prior pelvic irradiation resulting in overlapping fields
Use of levodopa in the last 30 days
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator