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

Study Overview
=================
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).

Official Title
-----------------
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

Conditions
-----------------
Carcinoma, Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Comparator: CT or MRI and FDG-PET
* Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gem/Cis or Gem/Carbo<br> | Radiation: Comparator: CT or MRI and FDG-PET<br>* Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle.<br>Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin<br>* Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean | 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. | Weeks 3 and 6 following chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of FDG SUVmean at Baseline | 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. | Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy | 
| Change in FDG-PET Uptake From Baseline to 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. | Baseline and Week 3 | 
| Change in FDG-PET Uptake From Week 3 to 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. | Week 3 and Week 6 | 
| Change in FGD-PET Uptake From Baseline to 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. | Baseline and Week 6 |