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NCT00591123 · ClinicalTrials.gov registry record · Phase 2
Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
A Phase 2 study of Unresectable Adenocarcinoma of the Esophagus and Metastatic Adenocarcinoma of the Esophagus, sponsored by Translational Oncology Research International.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT00591123: Completed Phase 2 study of Unresectable Adenocarcinoma of the Esophagus and Metastatic Adenocarcinoma of the Esophagus, sponsored by Translational Oncology Research International.
NCT00591123 is a Phase 2 study of Unresectable Adenocarcinoma of the Esophagus and Metastatic Adenocarcinoma of the Esophagus that has completed, run by Translational Oncology Research International. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591123, a Phase 2 study of Unresectable Adenocarcinoma of the Esophagus and Metastatic Adenocarcinoma of the Esophagus, has completed, sponsored by Translational Oncology Research International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer. Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.
Primary Outcome
Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since
Conditions Studied
Interventions
- DRUG 5-FU
- DRUG FOLFOX
- DRUG Erlotinib
Study Locations (2)
California
- Translational Oncology Research International (TORI) Network - Los Angeles
- UCLA Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2007-12 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT00591123 record still lists
NCT00591123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 4 conditions, with Unresectable Adenocarcinoma of the Esophagus appearing as the primary indexed condition, and to 3 interventions - of which 5-FU is the first listed.
NCT00591123 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00591123 about?
NCT00591123 is a clinical study titled "Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia". In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your can...
What is the current status of trial NCT00591123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2007-12. Estimated completion is 2015-09.
What conditions does trial NCT00591123 study?
This clinical trial studies the following conditions: Unresectable Adenocarcinoma of the Esophagus, Metastatic Adenocarcinoma of the Esophagus, Unresectable Adenocarcinoma of Gastric Cardia, Metastatic Adenocarcinoma of Gastric Cardia.
What interventions are being tested in trial NCT00591123?
The interventions under investigation include: 5-FU (DRUG), FOLFOX (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00591123?
This trial is sponsored by Translational Oncology Research International, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00591123 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00591123's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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