Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Aventis Pharmaceuticals; Sanofi-Synthelabo
• Treatments: Capecitabine; Docetaxel; Oxaliplatin

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.