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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599755
• Other study ID #: 0000-083
• Secondary ID: 2007_662
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2008
• Last updated: December 15, 2017
• Start date: January 1, 2009
• Est. completion date: April 13, 2011

Study information

• Verified date: December 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 13, 2011
• Est. primary completion date: June 10, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weeks 3 and 6 following chemotherapy
Secondary	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.	Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
Secondary	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.	Baseline and Week 3
Secondary	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.	Week 3 and Week 6
Secondary	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.	Baseline and Week 6