Conditions: Esophageal Cancer
Keywords: metastatic esophageal cancer erlotinib folfox advanced esophageal cancer unresectable esophageal cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

Brief summary:
The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.

Detailed description:
More than 50% of patients with advanced esophageal cancer present with disease that cannot be removed by surgery or has spread to other parts of the body. Improved therapies for patients with advanced esophageal cancer are therefore urgently needed. The epidermal growth factor receptor (EGFR) inhibitor erlotinib (in combination with chemotherapy) has lead to improved survival in patients with pancreatic and lung cancer. EGFR is a target in esophageal cancer therapy since its overexpression is associated with more aggressive disease and poor survival. Early studies have shown some clinical activity of EGFR inhibitors in this disease alone or in combination with chemotherapy. This study aims to explore how safe and effective treatment with erlotinib and FOLFOX is in patients with advanced esophageal or gastro-esophageal cancer.

Arms:
arm 1: COMBINATION THERAPY PHASE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-56. Patients also receive FOLFOX6 therapy comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1, 15, 29, and 43. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or no evidence of disease after course 2 or subsequent courses continue on to maintenance phase.

MAINTENANCE PHASE: Patients receive erlotinib hydrochloride PO QD on days 1-42. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: Erlotinib intervention 2: 5-fluorouracil intervention 3: Leucovorin intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: Tarceva single agent therapy: 150 mg/day PO intervention 2: 5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks intervention 3: 400 mg/m2 IV once every 2 weeks for 16 weeks intervention 4: 85 mg/m2 IV once every 2 weeks for 16 weeks

Protocol document: