NCT00247416

Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer

Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Susanne Arnold · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer. This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.

Detailed description

Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.

Conditions

• Stage IV Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
DRUG	Dexamethasone	16 mg bid for 4 days prior to each chemotherapy start.
DRUG	Carboplatin	AUC 6.0 intravenously over 30 minutes on day 5.

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2005-11-01
• Last updated: 2014-03-07
• Results posted: 2014-03-07

Locations

7 sites across 1 country: United States