2 Versus 6 Hour Oxaliplatin Infusions in Patients with Gastrointestinal Cancers

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Confirmed diagnosis of a gastrointestinal cancer

• Plan for 4 or more cycles of FOLFOX6 (fluorouracil [with leucovorin] andoxaliplatin) containing chemotherapy

• Histologically confirmed, measurable or evaluable disease. Patients with advanced ormetastatic disease should have at least one measurable lesion by Response EvaluationCriteria in Solid Tumors (RECIST) 1.1. Patients in the adjuvant treatment settingplanned to have > 4 cycles of FOLFOX-containing chemotherapy are eligible and willbe followed per standard of care

• Absolute neutrophil count (ANC) ≥ 1,500/µL (no white blood cell growth factorsallowed to meet requirement)

• Platelets ≥ 75,000/µL (may be transfused up to 72 hours prior to day 1 to meetrequirement)

• Hemoglobin ≥ 8 g/dL (may be transfused up to 72 hours prior to day 1 to meetrequirement)

• Creatinine clearance > 30 mL/min by Cockcroft-Gault, to preserve similar dosing (85mg/m²) for analysis

• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

• Signed informed consent

• Adequate birth control when appropriate

Exclusion Criteria:

• Any preexisting grade 2 or higher peripheral neuropathy

• Patients currently receiving anticancer therapies or who have received any focal orsystemic anticancer therapy within 14days of the start of FOLFOX6

• Known intolerance or hypersensitivity to any agent in FOLFOX6 or concurrent agents

• Patients who have any known severe and/or uncontrolled medical conditions such as:

• Unstable angina pectoris, symptomatic heart failure; (New York HeartAssociation class III or IV), myocardial infarction ≤ 6 months prior, seriousuncontrolled cardiac arrhythmia, or any other clinically significant cardiacdisease

• Active (acute or chronic) or uncontrolled severe infection, liver disease suchas cirrhosis, or decompensated liver disease

• Patients with any history of severe hemorrhage requiring ≥ 4 units of packed redblood cells (RBCs) in a 48-hour period

• Patients with a history of non-compliance to medical regimens or who are consideredpotentially unreliable or will not be able to complete the entire study

• Patients who are currently part of or have participated in any clinicalinvestigation with an investigational drug within 14days prior to dosing

• Pregnant or nursing (lactating) women

• Women of childbearing potential (WOCBP), defined as all women physiologicallycapable of becoming pregnant, must use highly effective methods of contraceptionduring the study and 8 weeks after. Highly effective contraception methods includecombination of any two of the following:

• Use of oral, injected or implanted hormonal methods of contraception or;

• Placement of an intrauterine device (IUD) or intrauterine system (IUS);

• Barrier methods of contraception: condom or occlusive cap (diaphragm orcervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;

• Total abstinence or;

• Male/female sterilization Women are considered post-menopausal and not ofchildbearing potential if they have had 12 months of natural (spontaneous)amenorrhea with an appropriate clinical profile (e.g. age appropriate, historyof vasomotor symptoms) or have had surgical bilateral oophorectomy (with orwithout hysterectomy) or tubal ligation at least six weeks prior torandomization. In the case of oophorectomy alone, only when the reproductivestatus of the woman has been confirmed by follow up hormone level assessment isshe considered not of childbearing potential