CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 68 enrolled
Drug / intervention
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin +1 moredrug
Likely dose
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin 1250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00599755
NCT00599755Phase 1Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Jan 24, 2008·Updated Jan 16, 2018

In Brief

A Phase 1 clinical trial evaluating Comparator: CT or MRI and FDG-PET and Gemcitabine and Cisplatin or Gemcitabine and Carboplatin for Carcinoma and Non-small Cell Lung Cancer. Completed, enrolled 68 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-small Cell Lung Cancer
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2008
Enrollment StartJan 1, 2009
Primary CompletionJun 10, 2010
Study CompletionApr 13, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.4 years ago

Interventions

Comparator: CT or MRI and FDG-PETradiation

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.

Gemcitabine and Cisplatin or Gemcitabine and Carboplatindrug

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.