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Sponsors and Collaborators: |
University of Pittsburgh Aventis Pharmaceuticals Hoffmann-La Roche |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177255 |
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.
Condition | Intervention | Phase |
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Cancer |
Drug: Docetaxel Drug: Capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas. |
Enrollment: | 43 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Kenneth Foon, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Cancer Institute ( University of Pittsburgh Cancer Institute ) |
Study ID Numbers: | 04-026 |
Study First Received: | September 12, 2005 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00177255 History of Changes |
Health Authority: | United States: Food and Drug Administration |
gastric stomach esophagus esophageal |
Antimetabolites Docetaxel Capecitabine Esophageal Disorder |
Esophageal Neoplasms Esophageal Cancer Esophageal Diseases Adenocarcinoma |
Antimetabolites Docetaxel Capecitabine Antimetabolites, Antineoplastic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |