Spots Global Cancer Trial Database for Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

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Trial Identification

Brief Title: Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

Official Title: A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma

Study ID: NCT00130689

Conditions

Esophageal Cancer

Gastric Cancer

Neoplasm Metastasis

Interventions

Cetuximab

Study Description

Brief Summary: Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated disease control among previously treated patients with metastatic esophageal and gastric cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle progression, induces apoptosis, and also inhibits processes important for tumor growth, such as cell invasion and angiogenesis.

Detailed Description: OBJECTIVES: Primary - To assess the response rate of single-agent cetuximab in patients with advanced esophageal or gastric cancer who have failed 1-2 prior chemotherapy regimens given in the metastatic setting. Secondary * To evaluate the duration of response, progression-free survival and overall survival. * To assess the safety of cetuximab. Exploratory - To assess whether levels of EGFR expression and/or EGFR mutation status correlates with response and toxicity of cetuximab. STATISTICAL DESIGN: This study used a two-stage design to evaluate efficacy of cetuximab based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 15%. If one or more patients enrolled in the stage one cohort (n=20 patients) achieved PR or better than accrual would proceed to stage two (n=16 patients). There was 36% probability of stopping the trial at stage one if the true OR rate was 5%. The probability that the regimen would be considered promising if the true OR rate was 5% was 10% and 80% if the true OR rate was 15%.