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

NCT ID: NCT00599755

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2011-04-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gem/Cis or Gem/Carbo

Group Type: EXPERIMENTAL

Comparator: CT or MRI and FDG-PET

Intervention Type: 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.

Gemcitabine and Cisplatin or Gemcitabine and Carboplatin

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2007_662

Identifier Type: OTHER

Identifier Source: secondary_id

0000-083

Identifier Type: -

Identifier Source: org_study_id