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The Role of Positron Emission Tomography (PET) During Erlotinib Treatment for Non-small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01000428
First received: October 22, 2009
Last updated: October 23, 2009
Last verified: October 2009
History of Changes
  Purpose

Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. Higher response rates were observed in a subset of patients with female gender, Asian ethnicity, no smoking history, mutations in EGFR tyrosine kinase, high EGFR gene copy number and adenocarcinoma histology. However, the therapeutic effect of Erlotinib is not confined to patients whose tumors harbor EGFR mutations and other predictors of efficacy of this agent. And these tests require time and sufficiently large specimens for processing, whereas many patients with advanced NSCLC are diagnosed based on cytology alone.

This study was designed to evaluate FLT-PET or FDG-PET usefulness in the early assessment of treatment response and in predicting patient outcome after erlotinib monotherapy for patients with non-small cell lung cancer prospectively. Changes in tumor FLT or FDG uptake 7 days after the initiation of treatment will be compared between responders and nonresponders based on subsequent CT scans.


Condition
Erlotinib
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of PET During Erlotinib Treatment to See the Responsiveness of Tumor Early in Patients With Non-small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Estimated Enrollment: 34
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Detailed Description:

  1. Primary objectives:

    To see whether the % change in SUVmax of a tumor with FLT-PET or FDG-PET at 7 days after initiating erlotinib treatment compared with baseline SUVmax (ΔSUVmax) would predict the tumor's responsiveness. And the responsiveness will be decided with the CT scan after 6 weeks of erlotinib treatment.

  2. Secondary objectives:

To compare ΔSUVmax and the degree of tumor shrinkage in longest diameter during erlotinib treatment.

To see ΔSUVmax in the tumors with stable disease. To see the time to progression and overall survival according to ΔSUVmax. To compare the result of FDG-PET and FLT-PET.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.

Criteria

Inclusion Criteria:

  • > 18 years of age
  • Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
  • At least 1 measurable lesion as defined by RECIST. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
  • ECOG PS 0-2
  • At least 3 weeks since the 1st line systemic therapy regimen prior to enrollment. Patients must have recovered to NCI CTCAE v3.0 grade I from all toxicities. But 1st line erlotinib treatment is also allowed.
  • At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
  • Patients must have adequate hematologic, renal and liver function as defined by Hb > 9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST (SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit).
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • Written and voluntary informed consent understood, signed and dated.

Exclusion Criteria:

  • Prior EGFR TKI treatment.
  • Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
  • Major surgery within 3 weeks prior to study enrollment.
  • Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
  • Severe medical illness or active infection that would impair the ability to receive erlotinib.
  • Pregnancy or breast feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000428

Contacts
Contact: Sang-We Kim, M.D. 82-2-3010-3215 swkim@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, SongPa-Gu, Korea, Republic of
Contact: Chang-Min Choi, Prof     82-2-3010-5902     ccm@amc.seoul.kr    
Sponsors and Collaborators
Asan Medical Center
  More Information

No publications provided

Responsible Party: Sang-We Kim/Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01000428     History of Changes
Other Study ID Numbers: AMC-2008-0511
Study First Received: October 22, 2009
Last Updated: October 23, 2009
Health Authority: Korea : Korean Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
NSCLC
Tarceva
Positron emission technology
FLT
FDG

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013