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NCT00397384 · ClinicalTrials.gov registry record · Phase 1
Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer
A Phase 1 study of Adenocarcinoma of the Rectum and Gastrointestinal Stromal Tumor, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT00397384 is a Phase 1 study of Adenocarcinoma of the Rectum and Gastrointestinal Stromal Tumor that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 43 participants, below the 908-participant average among 11 other Adenocarcinoma of the Rectum trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00397384, a Phase 1 study of Adenocarcinoma of the Rectum and Gastrointestinal Stromal Tumor, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG cetuximab
- DRUG erlotinib hydrochloride
Study Locations (1)
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00397384
The ClinicalTrials.gov registry entry for NCT00397384 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 908-participant average among 11 other Adenocarcinoma of the Rectum trials with a reported enrollment target (95% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Adenocarcinoma of the Rectum appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT00397384 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT00397384 about?
NCT00397384 is a clinical study titled "Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer". This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydr...
What is the current status of trial NCT00397384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2007-01. Estimated completion is 2013-06.
What conditions does trial NCT00397384 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Rectum, Gastrointestinal Stromal Tumor, Adenocarcinoma of the Colon, Advanced Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer.
What interventions are being tested in trial NCT00397384?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cetuximab (DRUG), erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00397384?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00397384 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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