NCT01356303

Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer

A Phase II Study of Docetaxel Combined With Cisplatin as the First Line Chemotherapy in Patients With Metastatic Non-small Cell Lung Cancer

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Guard Health Affairs · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh. Sub-sites will be open for patient accrual in selected centers in the Kingdom.

Detailed description

The cisplatin/docetaxel is established standard in the first line management of metastatic non small cell lung cancer in the United States, Europe and Asia. However, the safety and efficacy of this regimen was not studied systematically in Middle Eastern population. The aim of this study is to study the efficacy and safety of this regimen in our patient population

Conditions

• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	cisplatin, docetaxel	All patients met the eligibility criteria will undergo treatment with chemotherapy. Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of Dextrose 5% in Water or Normal Saline administered as a 1-hour intravenous infusion followed by cisplatin at dose of 75 mg/m2 administered as a 2-hour intravenous infusion every 3 weeks per cycle for totally 4-6 cycles.

Timeline

• Start date: 2009-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2011-05-19
• Last updated: 2016-05-13

Locations

1 site across 1 country: Saudi Arabia