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:||December 2014|
|Estimated Primary Completion Date:||August 2014 (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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356303
|Contact: AbdulRahman Jazieh, MD,MPH||0096612520088 ext email@example.com|
|Contact: Oncology Research||0096612520088 ext firstname.lastname@example.org|
|King Abdul Aziz Medical City for National Guard Health Affairs||Recruiting|
|Riyadh, Saudi Arabia, 11426|
|Contact: Abdularahman Jazieh, MD,MPH 0096612520088 ext 14688 email@example.com|
|Contact: Oncology Research 0096612520088 ext 14601 firstname.lastname@example.org|
|Principal Investigator:||Abdulrahman Jazieh, MD/MPH||King Abdul Aziz Medical City for National Guard|