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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00599755
First received: January 7, 2008
Last updated: May 22, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
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 More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00599755 History of Changes |
| Other Study ID Numbers: | MK-0000-083, 2007_662 |
| Study First Received: | January 7, 2008 |
| Results First Received: | April 10, 2012 |
| Last Updated: | May 22, 2012 |
| 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 Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013