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NCT00841035 · ClinicalTrials.gov registry record · Phase 2
7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00841035: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT00841035 is a Phase 2 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841035, a Phase 2 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
1.1 Primary Objective To evaluate the effects of short course preoperative erlotinib treatment in a panel of predictive biomarkers from a group of patients who undergo resection of pancreatic adenocarcinoma with curative intent. 1.2 Secondary Objectives 1.2.1 To analyze the effects of short course preoperative erlotinib treatment followed by postoperative erlotinib-gemcitabine therapy in the disease-free survival of patients who undergo curative intent resection of pancreatic adenocarcinoma. 1.2.2 To evaluate secondary endpoints of disease response such as duration of overall survival and patterns of recurrence for patients with resectable pancreatic cancer who undergo this treatment regimen. 1.2.3 To evaluate the plasma pharmacokinetics of erlotinib in pancreatic cancer patients both in the preoperative and postoperative setting, and to explore correlations between plasma and tumor erlotinib concentrations. 1.2.4 To develop a clinically relevant predictive assay of response to erlotinib based on selected biomarkers in endoscopic ultrasound-fine needle aspiration (EUS-FNA) specimens when it can be obtained at the time of pancreatic cancer diagnosis in chemotherapy-naive patients.
Primary Outcome
It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.
Interventions
- DRUG erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
Why NCT00841035 stopped before completion
NCT00841035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which erlotinib is the first listed.
NCT00841035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00841035 about?
NCT00841035 is a clinical study titled "7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients". 1.1 Primary Objective To evaluate the effects of short course preoperative erlotinib treatment in a panel of predictive biomarkers from a group of patients who undergo resection of pancreatic adenocarcinoma with curative intent. 1.2 Secondary Objectives 1.2.1 To analyze the effects of short cours...
What is the current status of trial NCT00841035?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2009-02. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00841035?
The interventions under investigation include: erlotinib (DRUG).
Who is sponsoring clinical trial NCT00841035?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00841035's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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