Nausea Clinical Trial
Official title:
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)
This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer. Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in patients receiving chemotherapy and radiation therapy
PRIMARY OBJECTIVES:
I. Discern the gastrointestinal toxicities associated with 5-FU (fluorouracil)/Gemcitabine
(gemcitabine hydrochloride) chemotherapy when combined with upper abdominal radiation
therapy.
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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
days 1-5.
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.
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