Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer (TAXIS01)
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.
Non-small Cell Lung Cancer Metastatic
Drug: cisplatin, docetaxel
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Docetaxel Combined With Cisplatin as the First Line Chemotherapy in Patients With Metastatic Non-small Cell Lung Cancer|
- Efficacy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Efficacy will be measured by calculating the following:
- Response rate using Response Evaluation Criteria for Solid Tumor criteria
- Time to Disease progression or Death
- Overall Survival
- Progression free survival, safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To determine progression free survival, median survival and 1 year survival of the studied population.
To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 4 parameters to be collected for all patients who receive the study regimen which are:
- Adverse Events
- Laboratory Assessments
- Vital Signs
- Physical Examinations
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Cisplatin, Docetaxel
Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of D5W or NS administered as a 1-hour intravenous infusion, followed by cisplatin at dose of 75 mg/m2administered as a 2-hour intravenous infusion every 3 weeks per cycle for 4-6 cycles
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356303
|King Abdul Aziz Medical City for National Guard Health Affairs|
|Riyadh, Saudi Arabia, 11426|
|Principal Investigator:||Abdulrahman Jazieh, MD/MPH||King Abdul Aziz Medical City for National Guard|