Determine the time to progression for the combination of erlotinib and bevacizumab in patients with previously treated metastatic cancer of the esophagus or gastroesophageal junction
We postulate that the addition of bevacizumab may increase the efficacy of erlotinib in patients with metastatic esophageal cancer, without adding significant toxicity. The non-overlapping toxicity profiles may allow the administration of the maximum tolerated doses for both agents without additive toxicities with the goal of demonstrating synergistic clinical activity. This combination has been previously tested in two studies for other malignancies with good tolerance and encouraging results.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Washington University School of Medicine
St Louis, Missouri, United States
Time to Progression (TTP)
* TTP is defined as the time from initiation of treatment to the date of documented progression. * The median of TTP with 95% confidence interval will be presented. * Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. * Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions.
Time frame: Median follow-up for TTP 6 weeks (6-18 weeks)
Overall Survival Rate (OS)
OS is defined as the time from initiation of treatment to the date of death for any reason.
Time frame: Median followup time from completion of treatment 325.5 days (44-401 days)
Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)
* CR = disappearance of all target lesions * PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD.
Time frame: Median follow-up for response 6 weeks (6-18 weeks)
Incidence and Severity of Toxicities
Grade 3 and higher toxicities using CTCAE Version 3.0.
Time frame: Median follow-up time for toxicities 72 days (72 days-156 days)
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