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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00290966 |
Phase II:
Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III survival comparison against the CDDP + 5-FU control arm.
Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2 test groups.
Phase III:
Primary objective: to detect a statistically significant increase in time to progression (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).
Main secondary objective: to detect a statistically significant increase in overall survival (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).
Other secondary objectives: to compare response rates, time to treatment failure, duration of response, safety profiles, quality of life and disease-related symptoms.Socio-economic data will be collected in order to be able to perform an analysis by country when necessary.
Condition | Intervention | Phase |
---|---|---|
Stomach Neoplasm |
Drug: docetaxel |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease |
Estimated Enrollment: | 610 |
Study Start Date: | October 1998 |
Estimated Study Completion Date: | May 2003 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Jaffer Ajani, MD | MD Anderson Cancer Center, Houston, Texas, US |
Principal Investigator: | E. Van Cutsem, MD | University hospital Gasthuisberg, Leuven, Belgium |
Study ID Numbers: | EFC6044 / XRP6976E-325, XRP6976E-325 |
Study First Received: | February 9, 2006 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00290966 |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
docetaxel stomach neoplasm |
Docetaxel Stomach Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin Gastrointestinal Diseases |
Fluorouracil Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer Recurrence |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |