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

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Trial phase: 
Phase I
Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00153881
Other unique IDs: 
D-9939
Official title: 

Docetaxel and Carboplatin Followed by a Dose-Ranging Study of Oral Capecitabine, Weekly Docetaxel, and Concomitant External Beam Radiotherapy for the Treatment of Patients With Stage II-III Carcinoma of the Esophagus and Gastro-Esophageal 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.

Number to be enrolled: 
48 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility criteria: 

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: 
Treatment
Single Group Assignment
Safety/Efficacy Study
Open Label
Non-Randomized
Uncontrolled
Interventions: 
Capecitabine (Xeloda)
Conditions treated: 
Esophageal Neoplasms
Funding
Funding types: 
OTHER
INDUSTRY
Sponsor: 
Dartmouth-Hitchcock Medical Center
Hoffmann-La Roche
Sanofi-Aventis
Dates
Date the data was first received: 
Wed, 2005-09-07
Trial start date: 
Tue, 2000-02-01
Trial completion date: 
Sat, 2012-12-01
Trial last updated: 
Wed, 2009-05-20