A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin
18 Years
N/A
Both
Carcinoma, Non-small Cell Lung Cancer
Trial Information
A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin
Inclusion Criteria:
- Has histologically or cytopathologically confirmed metastatic or locally advanced
stage IIIB/IV Non-small cell lung cancer (NSCLC)
- Has measurable disease
- Has not been previously treated with surgery (involving the thorax), radiation
(unless it was for a metastatic site), or chemotherapy for NSCLC
- Is 18 years of age or older
- Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG)
scale
- Women of childbearing potential have a negative pregnancy test
Exclusion Criteria:
- Is participating in or has participated in a study with an investigational compound
or device within 30 days or 5 half-lives of the start of treatment
- Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
- Abuses drugs or alcohol
- Is pregnant or breastfeeding
- Is Human Immunodeficiency Virus (HIV) positive
- Has active viral hepatitis
- Has hearing loss
- Has poorly controlled diabetes mellitus
- Is allergic to gemcitabine, cisplatin or carboplatin
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
Outcome Description:
Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Outcome Time Frame:
Weeks 3 and 6 following chemotherapy
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Spain: Ministry of Health
Study ID:
MK-0000-083
NCT ID:
NCT00599755
Start Date:
January 2009
Completion Date:
April 2011
Related Keywords:
- Carcinoma
- Non-Small Cell Lung Cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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