City of Hope Medical Center
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.
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of papaverine (PPV) in combination with radiation therapy (RT) for locally advanced rectal cancer (LARC). II. Describe the safety and tolerability of PPV in combination with standard of care (SOC) RT for LARC. SECONDARY OBJECTIVES: I. Determine the clinical complete response rate (cCR), and local-regional control rate of PPV in combination with RT for LARC. II. Determine the total mesorectal excision (ToME)-free survival, local-regional recurrence free survival (LRRFS), disease-free…
Inclusion Criteria: * 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 * Histologically confirmed rectal adenocarcinoma * Patient wants to pursue an organ preservation/non-operative management (NOM) approach after completion of tot…
Undergo blood and tissue sample collection
Undergo CT
Receive CC with mFOLFOX6 or CAPOX
Undergo fMRI
Undergo endoscopy
Undergo MRI
Given IV
Undergo RT
Undergo ToME
Arctuva estimate
Verify or correct the compensation shown for this listing.