Phase I/II Study of Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
Washington University School of Medicine
Summary
The purpose of this research study is to evaluate epacadostat when given with routine radiation therapy and chemotherapy (capecitabine and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the tumor.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Newly diagnosed pathologically-confirmed locally advanced rectal cancer (defined by 8th edition AJCC stage 2 or 3, or stage 1 not eligible for sphincter-sparing surgery) with plans to proceed with total neoadjuvant short course radiation as part of their neoadjuvant therapy as confirmed by treating physician * At least 18 years of age. * ECOG performance status 0, 1, or 2 * Adequate bone marrow and organ function as defined below: * Absolute neutrophil count ≥ 1.5 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin \> 9 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT)…
Interventions
- DrugEpacadostat
Drug provided.
- RadiationShort-course radiation therapy
Short-course pelvic radiation therapy, 5 Gy x 5 fractions over 1 week
- DrugCAPOX chemotherapy
Standard of care
- DrugFOLFOX chemotherapy
Standard of care
Locations (4)
- University of California Irvine - Chao Family Comprehensive Cancer CenterOrange, California
- Dana Farber Cancer InstituteBoston, Massachusetts
- Henry Ford Cancer InstituteDetroit, Michigan
- Washington University School of MedicineSt Louis, Missouri