Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). 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.
Primary Outcome
MTD is the highest dose at which 1 or fewer dose limiting toxicities (DLT's) are observed in 6 patients. DLT defined as any non-hematologic grade III/IV or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy. Response evaluated after two 14-day treatments of Docetaxel, 5-Fluorouracil and Oxaliplatin (One cycle = 28 days).
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 |
What the finished NCT00526110 record still lists
NCT00526110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00526110 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00526110's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02926729 · 98 participants · NA
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
- NCT03382977 · 98 participants · Phase 1
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
- NCT04577014 · 98 participants · Phase 1
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
- NCT04817618 · 98 participants · Phase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia