University of Kansas Medical Center

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

Yes

Criteria

Inclusion Criteria:

- * REGISTRATION ELIGIBILITY CRITERIA (STEP 1)

- Histologic confirmation of invasive cancer that is confirmed or suspected to
arise from the gastrointestinal (GI) tract

- Any stage for which FOLFOX-based chemotherapy is a clinically-indicated,
standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)

- Eligible primary tumor sites include the esophagus, gastroesophageal junction,
stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and
cancers of unknown primary with suspected GI origin

- Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based
chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is
permitted

- The planned duration of FOLFOX-based chemotherapy must be at least four cycles
(1 cycle = 14 days)

- Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior
to registration

- Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses
of oxaliplatin (≥ 65 mg/m^2) and infusional 5-FU (2400 mg/m^2/46 hours). Use of
the 5-FU bolus is at the discretion of the treating physician

- Patients who require primary prophylactic white blood cell growth factor with
cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are
not eligible

- History of hypersensitivity reaction to oxaliplatin or other platinum-based
drugs, to fluorouracil, or to leucovorin, and the excipients in their
formulations are not eligible

- Age ≥ 18 years

- ECOG performance status ≤ 2

- Absolute neutrophil count (ANC) ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin ≤ 3 x upper limit of normal (ULN)

- AST (SGOT)/ALT (SGPT) ≤ 5 x upper limit of normal (ULN)

- Calc. creatinine clearance ≥ 30 mL/min

- Not pregnant and not nursing, because this study involves agents that have
known genotoxic, mutagenic and teratogenic effects. Therefore, for women of
childbearing potential only, a negative pregnancy test done ≤ 30 days prior to
registration is required

- Patients with treated brain metastases are eligible if follow-up brain imaging
after CNS-directed therapy shows no evidence of progression

- Patients with known HIV infection are eligible if receiving effective
anti-retroviral therapy with undetectable viral load within 6 months prior to
registration

- Patients with known chronic hepatitis B virus (HBV) infection are eligible if
HBV DNA is undetectable when measured within 6 months prior to registration

- Patients with a known history of hepatitis C virus (HCV) infection are eligible
if HCV RNA is undetectable when measured at least 12 weeks after completion of
antiviral therapy

- Patients with known history or current symptoms of cardiac disease are eligible
if the New York Heart Association Functional Classification is class I or II

- Patients with a known history of congenital long QT syndrome are ineligible

- Patients with known DPD deficiency are ineligible

- * NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER
ELIGIBILITY:

- The non-patient provider participant is a medical oncologist or oncology
advanced practice provider with responsibility for signing and making necessary
modifications to chemotherapy orders for a subject assigned to the intervention
arm (Arm B). Non-patient participants may not be enrolled more than once over
the course of the study

- The non-patient participant must be proficient in the English language

- The non-patient participant must be age 21 years or older