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

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

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).

Study Overview

• Status: Completed
• 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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Gem/Cis or Gem/Carbo

Radiation: Comparator: CT or MRI and FDG-PET; 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.; Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin; 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.

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): June 10, 2010
• Study Completion (Actual): April 13, 2011

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: January 11, 2008
• First Posted (Estimate): January 24, 2008

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Carboplatin; Cisplatin
• Other Study ID Numbers: 0000-083; 2007_662 (Other Identifier: Merck)