Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Docetaxel and Oxaliplatin in Gastric Cancer
NCT00382720 · View on ClinicalTrials.gov ↗
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00382720
The ClinicalTrials.gov registry entry for NCT00382720 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00382720 reports 12 study locations spanning 2 distinct geographic areas — top geographies include Other, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00382720?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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