Early Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT00708448
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PET Imaging — RADIATION
    Patients will receive an FLT-PET scan, FDG-PET scan, a H215O-PET scan, and have a blood sample (15 cc, approximately 3 teaspoons) drawn for the genetic and protein studies. These studies will be done before patients begin taking erlotinib and bevacizumab.
  • Erlotinib — DRUG
    150 mg/day
  • Bevacizumab — DRUG
    15mg/kg q 21 days

Study Details

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 erlotinib.

Key Dates

First listed
Jul 2, 2008
Start date
Mar 28, 2008
Status verified
Feb 2025
Primary completion
Aug 12, 2010
Completion
Aug 12, 2010

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: All patients
    All participants enrolled.

Primary Outcome Measure

Provide reliable validated, PET imaging derived biomarkers and serum derived biomarkers for a better understanding of early clinical benefit from Avastin/Tarceva therapy, efficacy during Avastin/Tarceva therapy, and prognosis or other long term outcomes. [ Time Frame: December 2011 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Huntsman Cancer Institute· Salt Lake City, UT

Related Studies