Back to resultsPhase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
Primary Purpose
Carcinoma, Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: CT or MRI and FDG-PET
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
Sponsored by
About this trial
This is an interventional diagnostic trial for Carcinoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gem/Cis or Gem/Carbo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT00599755
First Posted
January 7, 2008
Last Updated
December 15, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00599755
Brief Title
Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
June 10, 2010 (Actual)
Study Completion Date
April 13, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gem/Cis or Gem/Carbo
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Comparator: CT or MRI and FDG-PET
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
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.
Time Frame
Weeks 3 and 6 following chemotherapy
Secondary Outcome Measure Information:
Title
Repeatability of FDG SUVmean at Baseline
Description
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.
Time Frame
Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
Title
Change in FDG-PET Uptake From Baseline to Week 3
Description
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.
Time Frame
Baseline and Week 3
Title
Change in FDG-PET Uptake From Week 3 to Week 6
Description
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.
Time Frame
Week 3 and Week 6
Title
Change in FGD-PET Uptake From Baseline to Week 6
Description
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.
Time Frame
Baseline and Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
We'll reach out to this number within 24 hrs