Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer

Phase 1

Completed

• Conditions: Esophageal Neoplasms
• Interventions: Drug: Capecitabine (Xeloda)

• Registration Number: NCT00153881
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

The primary objective is to determine the maximum tolerated dose of oral capecitabine, in combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.

Detailed Description

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.

Study Timeline

• Study Start: 2000-02
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Esophageal or gastroesophageal junction cancer that is locally advanced and surgically resectable (stage II or III disease).
• No prior therapy.
• Adequate organ function.

Exclusion Criteria

• Evidence of metastasis (celiac axis lymph nodes are allowed).
• Cervical esophageal tumors.
• Peripheral or auditory neuropathy grade >= 2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Capecitabine (Xeloda)	Docetaxel/Carboplatin every 3 weeks for 2 cycles then concommitant chemotherapy and radiation Docetaxel weekly for 5 doses without premedication, then Capecitabine will be given orally, one dose prior to each fraction or irradiation (28 cycles).

Primary Outcome Measures

Name	Time	Method
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.	Enrollment of first subject to accural of last subject/ and data analysis

Secondary Outcome Measures

Name	Time	Method
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.	Enrollment of first subject to accrual of last subject/ data analysis
To determine the reliability of clinical staging and antitumor response rate assessment using endoscopic ultrasound.	Enrollment of first subject to accrual of last subject/ data analysis of study.
To investigate the feasibility of assaying thymidine phosphorylase, cyclin B, MPM-2, and perturbations in cell cycle as potential markers of efficacy.	Enrollment of first subject to accrual of last/ data analysis of study.

Trial Locations

Locations (1)

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States