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

NCT00599755 | Completed Phase 1 Results

• 2 other identifiers: 0000-0832007_662
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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

Carcinoma; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Repeatability of FDG SUVmean at Baseline

  Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy

• Change in FDG-PET Uptake From Baseline to Week 3

  Baseline and Week 3

• Change in FDG-PET Uptake From Week 3 to Week 6

  Week 3 and Week 6

• Change in FGD-PET Uptake From Baseline to Week 6

  Baseline and Week 6

Study Arms (1)

Gem/Cis or Gem/Carbo

EXPERIMENTAL

Radiation: Comparator: CT or MRI and FDG-PET; Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin

Interventions

Comparator: CT or MRI and FDG-PET RADIATION

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.

Gem/Cis or Gem/Carbo

Gemcitabine and Cisplatin or Gemcitabine and Carboplatin DRUG

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.

Gem/Cis or Gem/Carbo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Magnetic Resonance Spectroscopy; Gemcitabine; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President,Global Clinical Development
• Organization: Merck Sharp and Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 24, 2008
• Study Start: January 1, 2009
• Primary Completion: June 10, 2010
• Study Completion: April 13, 2011
• Last Updated: January 16, 2018
• Results First Posted: June 27, 2012

Record last verified: 2017-12