| Eligibility Criteria |
Eligibility Criteria
- The patient must have an ECOG performance status of 0 or 1
- Patients must have histologically/pathologically confirmed Stage IIB, IIC
- No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry
- The distal extent of the tumor must be ≥ 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen
- The patient must have had an en bloc complete gross resection of tumor
- The resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera assay by Natera
- Tumor must be documented as microsatellite stable or have intact mismatch repair proteins
- The interval between surgery (post-operative Day 7) and Step 1/Study entry must be no more than 60 days.
- Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
- Absolute neutrophil count (ANC) must be ≥ 1500/mm3;
- Platelet count must be ≥ 100,000/mm3; and
- Hemoglobin must be ≥ 9 g/dL.
- total bilirubin must be ≤ ULN (upper limit of normal) for the lab and
alkaline phosphatase must be < 2.5 x ULN for the lab; and
AST and ALT must be < 2.5 x ULN for the lab.
- Adequate renal function within 28 days before Step 1/Study entry defined as serum creatinine ≤ 1.5 x ULN
Ineligibility Criteria
- Colon cancer histology other than adenocarcinom
- Tumor-related bowel perforation.
- Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Sensory or motor neuropathy ≥ grade 2, according to CTCAE v5.0.
Please contact Legacy Oncology Research for additional study inclusion/exclusion information. |
