S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
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|ClinicalTrials.gov Identifier: NCT00096031|
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : May 1, 2012
Last Update Posted : July 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Biological: cetuximab||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2010|
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
- Overall Survival at 6 Months [ Time Frame: every 3 weeks while on treatment, then every 3 months ]Time to death is measured from date of registration to date of death due to any cause.
- Time to Treatment Failure [ Time Frame: every 3 weeks while on treatment ]Time to treatment failure is measured from date of registration to date of first observation of progressive disease (as defined in the protocol), death due to any cause, symptomatic deterioration (as defined in the protocol), or early discontinuation of treatment.
- Time to Progression [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ]Progression free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration (as defined in the protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096031
Show 152 Study Locations
|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|