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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00599755
Recruitment Status : Completed
First Posted : January 24, 2008
Results First Posted : June 27, 2012
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Carcinoma Non-small Cell Lung Cancer Radiation: Comparator: CT or MRI and FDG-PET Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : June 10, 2010
Actual Study Completion Date : April 13, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean [ Time Frame: 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 :
  1. Repeatability of FDG SUVmean at Baseline [ Time Frame: 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.

  2. Change in FDG-PET Uptake From Baseline to Week 3 [ Time Frame: 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.

  3. Change in FDG-PET Uptake From Week 3 to Week 6 [ Time Frame: 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.

  4. Change in FGD-PET Uptake From Baseline to Week 6 [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599755


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00599755    
Other Study ID Numbers: 0000-083
2007_662 ( Other Identifier: Merck )
First Posted: January 24, 2008    Key Record Dates
Results First Posted: June 27, 2012
Last Update Posted: January 16, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
 Carboplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs