Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Arm, Phase II Study of Tarceva Plus FOLFOX6 in Patients With Unresectable or Metastatic Cancer of Esophagus or Gastroesophageal Junction|
- Progression Free Survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the number of participants with progression free survival after 6 months form the first day of the Erlotinib Run-In Phase for patients treated on study.
- Response Rate (RR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the number of participants with partial response (PR) or stable disease (SD) for the objective tumor response rate in the selected patient population treated with erlotinib and FOLFOX.
- To Determine the Time to Progression in This Population After Initiation of Erlotinib Alone, Following Erlotinib and FOLFOX Combination Chemotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To Determine Toxicity and Tolerability of the Erlotinib and FOLFOX Treatment Regimen in the Selected Patient Population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To Estimate the Correlation of Epidermal Growth Factor Receptor (EGFR) Gene Amplification and EGFR Gene Expression Levels in Esophageal Cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To Determine the Effects of Erlotinib on EGFR Signaling and Tumor Cell Survival in Esophageal Cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Tarceva and FOLFOX||
Tarceva single agent therapy: 150 mg/day PO
Other Name: tarcevaDrug: 5-fluorouracil
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 weeksDrug: leucovorin
400 mg/m2 IV once every 2 weeks for 16 weeksDrug: oxaliplatin
85 mg/m2 IV once every 2 weeks for 16 weeks
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.
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||W. Michael Korn, MD||University of California, San Francisco|