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NCT00708448 · ClinicalTrials.gov registry record · Phase 1
Early Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients
A Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00708448 is a Phase 1 study of Cancer and Non-Small Cell Lung Cancer that has completed, run by University of Utah. The registered enrollment target is 26 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00708448, a Phase 1 study of Cancer and Non-Small Cell Lung Cancer, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments using positron emission tomography (PET) imaging in 21 patients with Stage IIIB/IV or recurrent non-small cell lung cancer (NSCLC) and an early post therapy assessment at baseline and at various early time points (2 weeks in 7 patients, 4 weeks in 7 patients, and 6 weeks in 7 patients) after institution of erlotinib (anti-EGFR) (Tarceva) and bevacizumab (anti-VEGF) (Avastin) for first-line treatment of Stage IIIB/IV or recurrent non-squamous NSCLC. The proposed PET imaging and blood derived biomarkers trial is a companion study to an approved therapeutic trial (IRB# 24377). The therapeutic trial of erlotinib (Tarceva) and bevacizumab (Avastin) for first-line treatment of Stage IIIB/IV or recurrent lung cancer with drug costs exceeding $150,000 per patient/year (study drug budget exceeds $5 million) was funded for study at the HCI and the HICCP, statewide trial network. The proposed imaging study has been funded by the University of Utah Synergy Grant Program. The clinical imaging biomarkers will include an assessment of tumor metabolism \[Banrasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber\] (dynamic FDG-PET); tumor proliferation \[Rasey 2002,Shields 2001,Shields 1998, Vesselle 2002, Schwartz 2003\] (dynamic FLT-PET); tumor blood flow and perfusion( H215O-PET)\[Lodge 2000\]; and tumor blood volume of distribution ( H215O -PET)\[Lodge 2000\] in the same patient at baseline and then in the same patient at one of the post therapy time points (2 weeks, 4 weeks, or 6 weeks). The investigators hypothesize that by using a set of imaging derived biomarkers and biomarkers from blood they can predict response, either prior to or at an earlier time point than would normally be determined with standard imaging techniques, in patients with lung cancer receiving combined bevacizumab and
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Erlotinib
- RADIATION PET Imaging
Study Locations (1)
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2008-03-28 |
| Est. Completion | 2010-08-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00708448
The ClinicalTrials.gov registry entry for NCT00708448 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT00708448 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT00708448 about?
NCT00708448 is a clinical study titled "Early Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients". This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments using positron emission tomography (PET) imaging in 21 patients with Stage IIIB/IV or recurrent non-small cell lung cancer (NSCLC) and an early post therapy assessment at baseline and at various early time poin...
What is the current status of trial NCT00708448?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2008-03-28. Estimated completion is 2010-08-12.
What conditions does trial NCT00708448 study?
This clinical trial studies the following conditions: Cancer, Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00708448?
The interventions under investigation include: Bevacizumab (DRUG), Erlotinib (DRUG), PET Imaging (RADIATION).
Who is sponsoring clinical trial NCT00708448?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00708448 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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