The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
University of Chicago
Chicago, Illinois, United States
Overall Survival
Time from enrollment to death from any cause.
Time frame: Up to 60 months
Number of Biopsies Leading to an Adverse Event
Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis).
Time frame: 1 Month
Completion of Biopsy and Successful, Molecularly-based Treatment Assignment
Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).
Time frame: Up to 1 month
Adverse Event From Serial Biopsy for Second-line Treatment
Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
Time frame: Up to 60 Months
Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment
Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).
Time frame: Up to 60 months
Adverse Event From Serial Biopsy for Third-line Treatment
Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
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Ramucirumab
Nivolumab
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Time frame: Up to 60 months
Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment
Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).
Time frame: Up to 60 months