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NCT00130689 · ClinicalTrials.gov registry record · Phase 2
Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer
A Phase 2 study of Gastric Cancer and Esophageal Cancer, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 4
- Study locations
NCT00130689: Completed Phase 2 study of Gastric Cancer and Esophageal Cancer, sponsored by Dana-Farber Cancer Institute.
NCT00130689 is a Phase 2 study of Gastric Cancer and Esophageal Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 43 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00130689, a Phase 2 study of Gastric Cancer and Esophageal Cancer, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 4
- Study locations
Study Summary
Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated disease control among previously treated patients with metastatic esophageal and gastric cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle progression, induces apoptosis, and also inhibits processes important for tumor growth, such as cell invasion and angiogenesis.
Primary Outcome
Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after
Conditions Studied
Interventions
- DRUG Cetuximab
Study Locations (4)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
- North Shore Medical Center Cancer Center - Peabody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2005-07 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
What the finished NCT00130689 record still lists
NCT00130689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cetuximab is the first listed.
NCT00130689 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00130689 about?
NCT00130689 is a clinical study titled "Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer". Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR thro...
What is the current status of trial NCT00130689?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2005-07. Estimated completion is 2010-09.
What conditions does trial NCT00130689 study?
This clinical trial studies the following conditions: Gastric Cancer, Esophageal Cancer, Neoplasm Metastasis.
What interventions are being tested in trial NCT00130689?
The interventions under investigation include: Cetuximab (DRUG).
Who is sponsoring clinical trial NCT00130689?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00130689 being conducted?
This trial has 4 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00130689's enrollment target sits among peer trials
43 126th of 153 higher than 28 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer 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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