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NCT00526110 · ClinicalTrials.gov registry record · Phase 1
Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT00526110: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00526110 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 98 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00526110, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
Phase I Objectives Primary: 1\. The primary objective of this study is to determine the maximum tolerated dose (MTD) of Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated, locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ). Secondary: 1\. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination. Phase II Objectives Primary: 1\. To assess time to cancer progression to D-FOX treatment regimen. Secondary: 1. To assess response rate to D-FOX treatment regimen. 2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination treatment regimen. 3. Determine overall survival. 4. Perform an exploratory investigation into the effect of D-FOX on phenotypic abnormalities in blood.
Interventions
- DRUG Docetaxel
- DRUG Oxaliplatin
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2004-08 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00526110
The ClinicalTrials.gov registry entry for NCT00526110 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00526110 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00526110 about?
NCT00526110 is a clinical study titled "Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients". Phase I Objectives Primary: 1\. The primary objective of this study is to determine the maximum tolerated dose (MTD) of Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated, locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal ju...
What is the current status of trial NCT00526110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2004-08. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00526110?
The interventions under investigation include: Docetaxel (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00526110?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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