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Ramucirumab Plus Irinotecan in Patients with Previously Treated Advanced Gastric or Gastro-Esophageal Junction Adenocarcinoma
The purpose of this research study is to look at how esophageal or gastric cancers respond to study treatment with two drugs in combination: ramucirumab plus irinotecan.
To determine the progression-free survival (PFS) with irinotecan plus ramucirumab in patients with metastatic gastric and gastro-esophageal junction cancer who have progressed after first line chemotherapy. Secondary Objectives 1. To determine the overall survival (OS) of patients treated with irinotecan plus ramucirumab. 2. To determine time to progressive disease (TTP) in patients treated with irinotecan plus ramucirumab. 3. To determine the best overall response (BOR) of confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD) or Progressive disease (PD) in patients treated with irinotecan plus ramucirumab. 4. To determine the objective response rate (ORR) (defined as confirmed CR + confirmed PR) in patients treated with irinotecan plus ramucirumab. 5. To determine clinical benefit rate (CBR) (percentage of combined patients who have achieved confirmed CR, confirmed PR and SD) in patients treated with irinotecan plus ramucirumab. 6. To evaluate toxicity and tolerability of irinotecan plus ramucirumab as measured by NCI-CTCAE version 4.03.
CPT-11 (irinotecan); Camptosar (irinotecan); IMC-1121B (Ramucirumab); Ramucirumab (); irinotecan ()