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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
History of Changes

March 20, 2007
August 2, 2012
December 2004
July 2012   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00450567 on ClinicalTrials.gov Archive Site
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Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy
Monitoring Targeted Lung Cancer Treatments With FDG-PET/CT

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.
Lung Cancer
  • Procedure: computed tomography
  • Procedure: positron emission tomography
  • Radiation: fludeoxyglucose F 18
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00450567
CDR0000423222, P50CA086306, P30CA016042, UCLA-0410068-01
No
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Johannes Czernin, MD Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP