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NCT00380029 · ClinicalTrials.gov registry record · Phase 2
Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer
A Phase 2 study of Bladder Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT00380029: Completed Phase 2 study of Bladder Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00380029 is a Phase 2 study of Bladder Cancer that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 27 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00380029, a Phase 2 study of Bladder Cancer, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well erlotinib works when given before and after surgery in treating patients with muscle-invasive bladder cancer.
Primary Outcome
Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Gene expression of pre-treatment and post-treatment tumor samples were analyzed to define molecular determinants of response or resistance to epidermal growth factor receptor (EGFR) inhibition. Both in vitro and in vivo EGFR-associated signatures were evaluated on pre-treatment bladder tumors. Candidate m
Conditions Studied
Interventions
- DRUG Erlotinib
- PROCEDURE Radical Cystectomy
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-05 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT00380029 record still lists
NCT00380029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Erlotinib is the first listed.
NCT00380029 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00380029 about?
NCT00380029 is a clinical study titled "Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer". RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib after surgery may kill any tumor cells that rem...
What is the current status of trial NCT00380029?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2006-05. Estimated completion is 2014-06.
What conditions does trial NCT00380029 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT00380029?
The interventions under investigation include: Erlotinib (DRUG), Radical Cystectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00380029?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00380029 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00380029's enrollment target sits among peer trials
27 141st of 175 higher than 33 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder 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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