Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy

Inclusion Criteria:

Histologically or cytologically confirmed locally advanced or metastatic colon or rectal adenocarcinoma
Intent to treat the patient with a leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) chemotherapy regimen containing fluorouracil (5-FU), leucovorin, and oxaliplatin according to clinical standard practice; the intent should be to dose oxaliplatin at 85 mg/m^2 on an every 2 week basis
Treatment with any additional Food and Drug Administration (FDA)-approved biologic agent (i.e. bevacizumab, cetuximab, or panitumumab) is allowed according to standard practice
Prior radiation or surgery is allowed, but should be finished at least 2 weeks prior to study enrollment; if a participant has prior radiation therapy, at least one measurable lesion outside of the radiation field should be available for the evaluation of response to chemotherapy
Any number of prior therapies other than oxaliplatin is allowed
Zubrod performance status equal to or less than 2 (Karnofsky equal to or greater than 50%)
Life expectancy of at least 3 months
Absolute neutrophil count greater than or equal to 1,500/microL
Platelets greater than or equal to 100,000/microL
Total bilirubin less than 3 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase) less than or equal to 5 x ULN
Creatinine less than 1.5 x ULN
Women of child bearing potential must not be pregnant; a pre-study pregnancy test must be negative
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation
Men must agree to use adequate contraception (barrier method or abstinence) prior to study entry and for 30 days after study participation
Ability to understand and willing to sign a written informed consent document

Exclusion Criteria:

Prior treatment with oxaliplatin
Patients must not receive concomitant radiation
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 study requirements
Participants who are pregnant or nursing
Participants who are allergic to any platinum agent
Participants who have more than grade 1 peripheral neuropathy