Esophageal Cancer Clinical Trial
Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
Summary
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Full Description
Upon determination of eligibility, patients will be receive:
Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy
If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy
Eligibility Criteria
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.
Must be surgical candidates
No previous treatment for esophageal cancer
Must have measurable or evaluable disease
Able to perform activities of daily living with minimal to no assistance
Adequate bone marrow, liver and kidney function
Provide written informed consent
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Tumor location in the proximal esophagus
Metastatic disease or locally advanced cancer
Moderate to severe peripheral neuropathy
Serious pre-existing medical illnesses
Significant heart disease
Treated for an invasive cancer within the previous 5 years
Women who are pregnant or breast-feeding
Age < 18 years
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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There are 7 Locations for this study
Beverly Hills California, 90211, United States
Jacksonville Florida, 32256, United States
Atlanta Georgia, 30342, United States
Gainesville Georgia, 30501, United States
Marietta Georgia, 30060, United States
Louisville Kentucky, 40207, United States
Nashville Tennessee, 37203, United States
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