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

• Status: Completed
• Trial end date: 2011-04-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Carboplatin; Cisplatin; Gemcitabine

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