Conditions: Chemotherapy-Induced Nausea and Vomiting
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 848
Healthy volunteers: no

Brief summary:
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Detailed description:

Arms:
arm 1: Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours. arm 2: Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.

Interventions: intervention 1: aprepitant intervention 2: Comparator: ondansetron intervention 3: Comparator: dexamethasone intervention 4: Comparator: fosaprepitant dimeglumine intervention 5: Comparator; Placebo (unspecified) intervention 6: Comparator; Placebo (unspecified)
Intervention descriptions: intervention 1: aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period. intervention 2: Ondansetron 8 mg capsule Three day treatment period. intervention 3: dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period. intervention 4: fosaprepitant dimeglumine 115 mg intervention 5: dexamethasone 12mg Pbo tablets. intervention 6: Aprepitant 80 mg \& 125 mg Pbo capsules.

Protocol document: