Conditions: Stomach Cancer Esophageal Cancer
Keywords: cancer stomach esophagus gastroesophageal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 168
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.

Detailed description:

Arms:
arm 1: * Oxaliplatin 85 milligrams per square meter (mg/m\^2) given on Day 1 of a 2-week cycle
* Leucovorin 400 mg/m\^2 given on Day 1 of a 2-week cycle
* 5-Fluorouracil (5-FU) 400 mg/m\^2 bolus given on Day 1 of a 2-week cycle
* 5-FU 2400 mg/m\^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle
* Ramucirumab 8 milligrams per kilogram (mg/kg) given on Day 1 of a 2-week cycle

Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met arm 2: * Oxaliplatin 85 mg/m\^2 given on Day 1 of a 2-week cycle
* Leucovorin 400 mg/m\^2 given on Day 1 of a 2-week cycle
* 5-FU 400 mg/m\^2 bolus given on Day 1 of a 2-week cycle
* 5-FU 2400 mg/m\^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle
* Placebo given on Day 1 of a 2-week cycle

Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Interventions: intervention 1: Ramucirumab intervention 2: Placebo intervention 3: Oxaliplatin intervention 4: Leucovorin intervention 5: 5-Fluorouracil
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously intervention 5: Administered intravenously

Protocol document: