S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II|
- Overall Survival at 6 Months [ Time Frame: every 3 weeks while on treatment, then every 3 months ] [ Designated as safety issue: No ]
- Time to Treatment Failure [ Time Frame: every 3 weeks while on treatment ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Other Name: Erbitux
- Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
- Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 6-14 months.
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|Study Chair:||Philip J. Gold, MD||Swedish Cancer Institute at Swedish Medical Center - First Hill Campus|
|Study Chair:||Syma Iqbal, MD||University of Southern California|