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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Non-small Cell Lung Cancer

Carcinoma

Treatments

Radiation: Comparator: CT or MRI and FDG-PET

Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00599755

0000-083

2007_662 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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