Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT00153881|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms||Drug: Capecitabine (Xeloda)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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).
Drug: Capecitabine (Xeloda)
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).
- 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 ]
- 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 ]
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153881
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||James R Rigas, MD||Norris Cotton Cancer Center|