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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)

NCT00599755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-01-16

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2010-06-10
Completion
2011-04-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00599755 on ClinicalTrials.gov