A Feasibility Study to Discern the Tolerability of 5-FU/Gemcitabine Based Chemotherapy Concurrent With Upper Abdominal Radiation and the Utility of Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV)
I. Discern the gastrointestinal toxicities associated with 5-FU (fluorouracil)/Gemcitabine
(gemcitabine hydrochloride) chemotherapy when combined with upper abdominal radiation
II. Determine if the addition of prophylactic Aprepitant/5HT-3/Dexamethasone therapy to
standard chemoradiation for patients with pancreatic cancer results in less nausea and
vomiting when compared to historical controls.
I. To determine the impact of prophylactic Aprepitant/5HT-3/Dexamethasone therapy on the
impact of emesis on daily living, as measured using the MASCC Antiemesis (MAT) tool.
CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks.
Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once
weekly and either fluorouracil IV continuously or capecitabine orally (PO) twice daily on
PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant
PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease
progression or unacceptable toxicity.
CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and
prophylactic therapy, patients without disease progression or a declining performance status
receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats
every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation
Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.
Over 10 weeks
Wake Forest University
United States: Institutional Review Board
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