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

NCT00708448 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HCI26198
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 erlotinib.

Conditions

Cancer; Non Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  December 2011

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Radiation: PET Imaging; Drug: Erlotinib; Drug: Bevacizumab

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.

Also known as: FLT-PET scan, FDG-PET scan, a H215O-PET scan

All patients

Erlotinib DRUG

150 mg/day

All patients

Bevacizumab DRUG

15mg/kg q 21 days

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must be enrolled in the the therapeutic trial (IRB # 24377) with non-squamous non-small cell lung cancer (NSCLC) treated with combined erlotinib (Tarceva) (150 mg/day)and bevacizumab (Avastin) (15mg/kg q 21 days) as first line therapy.
• After entry into the study, patients are expected to be followed for at least 2 months as part of standard of care.
• All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
• The patient, if female, must be postmenopausal for a minimum of one year or surgically sterile, or on one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera or Norplant. These criteria can be waived at the discretion of the investigator if the patient's tumor is considered life threatening and the one month wait required is not in the best interest of the patient. Negative pregnancy test is accepted.
• Pre-treatment radiological clinical scans/studies (Gd- enhanced MRI or CT to document Stage IIIB/IV or recurrent NSCLC) must be performed within 30 days of study entry.

You may not qualify if:

• Patients will be receiving erlotinib (Tarceva) (150 mg/day)and bevacizumab (Avastin) (15mg/kg q 21 days) as part of the therapeutic trial. Enrollment may not occur if the patient does not meet the enrollment criteria for the therapeutic trial
• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
• Patients who are pregnant or lactating or who suspect they might be pregnant.
• Adult patients who require monitored anesthesia for PET scanning.
• HIV positive patients due to the previous toxicity noted with FLT.
• Claustrophobia or inability to remain stationary within the PET scanner for 90 minutes.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Links

• NCT00585377 (Companion Protocol)

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Magnetic Resonance Spectroscopy; Erlotinib Hydrochloride; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jeffrey Yap, PhD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: March 28, 2008
• Primary Completion: August 12, 2010
• Study Completion: August 12, 2010
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

US (1)