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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00599755
First received: January 7, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 3 and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]

    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.



Enrollment: 68
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599755

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00599755     History of Changes
Other Study ID Numbers: 0000-083, 2007_662
Study First Received: January 7, 2008
Results First Received: April 10, 2012
Last Updated: October 25, 2013
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014