Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer; Carcinoma
• Interventions: Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin

• Registration Number: NCT00599755
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-24
• Study Start: 2009-01-01
• Primary Completion: 2010-06-10
• Study Completion: 2011-04-13
• Results First Submitted: 2012-04-10
• Results First Submitted QC: 2012-05-22
• Results First Posted: 2012-06-27
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gem/Cis or Gem/Carbo	Gemcitabine and Cisplatin or Gemcitabine and Carboplatin	-

Primary Outcome Measures

Name	Time	Method
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean	Weeks 3 and 6 following chemotherapy	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.

Secondary Outcome Measures

Name	Time	Method
Repeatability of FDG SUVmean at Baseline	Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy	Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. 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.
Change in FDG-PET Uptake From Baseline to Week 3	Baseline and Week 3	Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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.
Change in FDG-PET Uptake From Week 3 to Week 6	Week 3 and Week 6	Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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.
Change in FGD-PET Uptake From Baseline to Week 6	Baseline and Week 6	Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.; 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.