Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT00318903|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : January 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Cancer of the Esophagus Esophagus Cancer Esophageal Neoplasm Cancer of Esophagus||Drug: Irinotecan (drug) Drug: Taxotere (drug) Procedure: Radiotherapy (procedure) Procedure: Esophagectomy (procedure)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||April 2006|
Taxotere and Irinotecan is given intravenously for 3 consecutive weeks with a one-week break before radiotherapy for 5-6 weeks. A combination of Taxotere and Irinotecan will then be administered simultaneously with the radiotherapy.
Drug: Irinotecan (drug)
50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
Other Name: Camptosar
Drug: Taxotere (drug)
Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
Other Name: Docetaxel
Procedure: Radiotherapy (procedure)
Radiotherapy will be given in 28 fractions over 5-6 weeks at 1.8 Gy per fraction for a total of 50.4 Gy. This will begin concurrently with chemotherapy on Day 29 of treatment.
Procedure: Esophagectomy (procedure)
After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.
- The determination of pathologic response in patients who undergo surgical resection. [ Time Frame: Approximately 14 weeks before eligible patients have surgery ]
- To assess the overall survival, time to treatment failure, and quality of life in patients who receive any therapy [ Time Frame: Approximately 4 months ]
- To assess the toxicities associated with this treatment and any impact on surgery. [ Time Frame: Approximately 4 months ]
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): NCT00318903
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||James A. Posey, M.D.||University of Alabama at Birmingham|