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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborators: |
Aventis Pharmaceuticals Hoffmann-La Roche |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00177255 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Principal Investigator: | Kenneth Foon, MD | University of Pittsburgh |
More Information
| 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 Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Fluorouracil Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |