Genotype-Guided Dosing of Irinotecan Versus Standard of Care for the Treatment of Stage I-IV Pancreatic Cancer and Stage III-IV Colorectal Cancer, GENOCARE Study

Inclusion Criteria

• Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment
• Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin =< institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional ULN
• Creatinine =< institutional ULN OR glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2
• Measurable or non-measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm ( >= 2 cm) with conventional techniques or as >= 10 mm ( >= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
• Patient with symptomatic brain metastasis must have had local treatment (i.e., radiation) of their brain metastasis completed at least 1 day prior to enrollment and be on stable dose of steroids or off steroids at the time of enrollment. Patients with untreated, asymptomatic brain metastasis, as determined by the treating physician, may be enrolled if their disease can be reasonably controlled with chemotherapy
• The effects of chemotherapy agents on the developing human fetus are unknown, and potentially teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of targeted agent administration
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients who received prior treatment with irinotecan are excluded
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician
• Pregnant women are excluded from this study
• Patients who are not planned for treatment of their cancer (i.e., refuse treatment, or are referred to hospice as their current treatment plan) are excluded from this study