NCT02550119

Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy

A Pilot Study to Evaluate the Safety and Efficacy of Aprepitant in Combination With Dolasetron and Dexamethasone for the Prevention of Nausea and Vomiting Following Oxaliplatin-containing Regimen Which Includes 5-FU.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the incidence and severity of acute and delayed nausea and vomiting associated with oxaliplatin-containing regimens in patients with gastrointestinal (GI) malignancy. II. To estimate the percent of patients who have experienced nausea and vomiting with their first or second cycle of oxaliplatin-containing regimen, and would consent to randomization to standard antiemetic therapy with or without aprepitant. III. To obtain preliminary data on the safety and efficacy of aprepitant, in combination with dolasetron (dolasetron mesylate) and dexamethasone, in patients receiving oxaliplatin-containing regimen. IV. To report on medication compliance with antiemetic medications (dexamethasone and aprepitant or placebo) scheduled to be taken at home on days 2 and 3 for all randomized patients (day 1 = day of treatment). OUTLINE: Patients receive standard antiemetics comprising dolasetron mesylate orally (PO) or intravenously (IV) and dexamethasone PO or IV during course 1 of oxaliplatin-containing chemotherapy. Patients experiencing any grade 1-4 nausea and vomiting\* are randomized to 1 of 2 treatment arms. ARM I: Patients receive dolasetron mesylate PO or IV, dexamethasone PO or IV, and aprepitant PO 1 day before chemotherapy and dexamethasone PO and aprepitant PO on days 2 and 3 after chemotherapy begins during course 2-3. ARM II: Patients receive dolasetron mesylate and dexamethasone as in Arm I and placebo PO 1 day before chemotherapy and dexamethasone PO and placebo PO on days 2 and 3 after chemotherapy begins during courses 2-3. In both arms, treatment continues in the absence of unacceptable toxicity. NOTE: \* Patients not developing nausea and vomiting until the second course of treatment are also randomized during courses 3 and 4 of chemotherapy. After completion of study treatment, patients are followed up periodically.

Conditions

• Malignant Digestive System Neoplasm
• Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Aprepitant	Given PO
DRUG	Dexamethasone	Given PO or IV
DRUG	Dolasetron Mesylate	Given PO or IV
DRUG	Placebo	Given PO

Timeline

• Start date: 2006-04-19
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2015-09-15
• Last updated: 2017-03-28

Locations

1 site across 1 country: United States