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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Sanofi-Aventis Hoffmann-La Roche |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00153881 |
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.
Condition | Intervention | Phase |
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Esophageal Neoplasms |
Drug: Capecitabine (Xeloda) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | February 2000 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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).
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Drug: Capecitabine (Xeloda)
Neoadjuvant Chemotherapy: Docetaxel every 3 weeks for 2 cycles Carboplatin every 3 weeks for 2 cycles with prophylactic antibiotics and antiemetics as needed. Concomitant chemotherapy and radiation: Docetaxel weekly for 5 doses without premedication Capecitabine orally, one dose prior to each fraction of irradiation (28 cycles). |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James R Rigas, MD | 603-650-6344 | James.R.Rigas@Dartmouth.Edu |
Contact: Heidi E McAllister | 603-650-5475 | Heidi.E.McAllister@Dartmouth.EDU |
United States, New Hampshire | |
Norris Cotton Cancer Center | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
Principal Investigator: James R Rigas, MD |
Principal Investigator: | James R Rigas, MD | Norris Cotton Cancer Center |
Responsible Party: | Dartmouth-Hitchcock Medical Center ( James R. Rigas, MD ) |
Study ID Numbers: | D-9939 |
Study First Received: | September 7, 2005 |
Last Updated: | May 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00153881 History of Changes |
Health Authority: | United States: Institutional Review Board |
Esophageal Cancer Trimodality Capecitabine Xeloda |
Gastro-esophageal Neoplasm Carcinoma of the Esophagus Esophageal Cancer |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Antiemetics Esophageal Cancer Carboplatin |
Carcinoma Docetaxel Anti-Bacterial Agents Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Carboplatin |
Pharmacologic Actions Docetaxel Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |