Primary Outcome Measures:
- To determine the maximum tolerated dose of oral capecitabine in combination with fixed doses of weekly docetaxel and concurrent radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction. [ Time Frame: Enrollment of first subject to accural of last subject/ and data analysis ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine clinical and pathological response rate, rate of resectability, duration of response, and patterns of failure for patients with esophageal and gastroesophageal junction cancers. [ Time Frame: Enrollment of first subject to accrual of last subject/ data analysis ] [ Designated as safety issue: No ]
- To determine the reliability of clinical staging and antitumor response rate assessment using endoscopic ultrasound. [ Time Frame: Enrollment of first subject to accrual of last subject/ data analysis of study. ] [ Designated as safety issue: No ]
- To investigate the feasibility of assaying thymidine phosphorylase, cyclin B, MPM-2, and perturbations in cell cycle as potential markers of efficacy. [ Time Frame: Enrollment of first subject to accrual of last/ data analysis of study. ] [ Designated as safety issue: No ]
This dose-ranging trial is designed to establish the phase II dose of capecitabine that can safely be given with docetaxel and radiation therapy for the treatment of patients with cancer of the esophagus and gastroesophageal junction. The docetaxel dose of 15 mg/m2/week, 5-fluorouracil dose of 200 mg/m2/week, and 50.4 Gy of thoracic radiation has been found to be the recommended doses from our initial phase I trial (DMS D9724). The Phase I study has been modified in an attempt to improve the pathological complete response rate by increasing the 5-fluorouracil exposure during thoracic radiation by replacing it with oral capecitabine. Capecitabine generates 5-fluorouracil selectively in tumor cells. This sequentially designed study of EUS staging, molecular analysis, neoadjuvant chemotherapy, concomitant chemotherapy and radiation, and surgical resection continues to expand our collaborative experience at Dartmouth Hitchcock in the treatment of cancer of the esophagus and gastroesophageal junction.