Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00450567
First received: March 20, 2007
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.

PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.


Condition Intervention
Lung Cancer
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring Targeted Lung Cancer Treatments With FDG-PET/CT

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Correlation of glucose metabolic response with progression-free survival, overall survival, and changes in tumor size as measured by fludeoxyglucose F 18 positron emission tomography/CT scan [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2004
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.

OUTLINE: This is a prospective study.

Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects diagnosed with non-small cell lung cancer (stage III B or stage IV) and will be treated with an experiemntal drug or a combination of chemotherapy and new drugs, as part of standarad of care or because of enrollment in a study protocol.

Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer
  • Any disease stage allowed
  • Undergoing targeted treatment

Exclusion Criteria:

None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450567

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Johannes Czernin, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00450567     History of Changes
Other Study ID Numbers: CDR0000423222, P50CA086306, P30CA016042, UCLA-0410068-01
Study First Received: March 20, 2007
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

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

ClinicalTrials.gov processed this record on April 15, 2014