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NCT00382720 · ClinicalTrials.gov registry record · Phase 2
Docetaxel and Oxaliplatin in Gastric Cancer
A Phase 2 study of Stomach Neoplasms, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 275
- Enrollment target
- 12
- Study locations
NCT00382720: Completed Phase 2 study of Stomach Neoplasms, sponsored by Sanofi.
NCT00382720 is a Phase 2 study of Stomach Neoplasms that has completed, run by Sanofi. The registered enrollment target is 275 participants, roughly in line with the 281-participant average among 10 other Stomach Neoplasms trials with a reported enrollment target. The trial reports 12 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00382720, a Phase 2 study of Stomach Neoplasms, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 275 participants
- Enrollment target
- 12
- Study locations
Study Summary
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population. Primary objective: * To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II). Secondary objectives: * To establish the safety profile. * To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria * To assess the Overall Survival (OS)
Primary Outcome
The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.
Conditions Studied
Interventions
- DRUG Docetaxel + Oxaliplatin
- DRUG Docetaxel + Oxaliplatin + 5-FU
- DRUG Docetaxel + Oxaliplatin + Capecitabine
Study Locations (12)
Other
- Sanofi-Aventis Administrative Office - Diegem
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Frankfurt
- Sanofi-Aventis Administrative Office - Budapest
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Porto Salvo
- Sanofi-Aventis Administrative Office - Moscow
- Sanofi-Aventis Administrative Office - Barcelona
- Sanofi-Aventis Administrative Office - Geneva
- Sanofi-Aventis Administrative Office - Istanbul
- Sanofi-Aventis Administrative Office - Guildford Surrey
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00382720 record still lists
NCT00382720 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 281-participant average among 10 other Stomach Neoplasms trials with a reported enrollment target.
The record links to 1 condition, with Stomach Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel + Oxaliplatin is the first listed.
NCT00382720 lists 12 locations in 2 states (Other, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00382720 about?
NCT00382720 is a clinical study titled "Docetaxel and Oxaliplatin in Gastric Cancer". This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal d...
What is the current status of trial NCT00382720?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 275 participants. The study started on 2006-09. Estimated completion is 2010-04.
What conditions does trial NCT00382720 study?
This clinical trial studies the following conditions: Stomach Neoplasms.
What interventions are being tested in trial NCT00382720?
The interventions under investigation include: Docetaxel + Oxaliplatin (DRUG), Docetaxel + Oxaliplatin + 5-FU (DRUG), Docetaxel + Oxaliplatin + Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00382720?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00382720 being conducted?
This trial has 12 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00382720's enrollment target sits among peer trials
275 3rd of 10 higher than 8 of 10 other Stomach Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stomach Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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