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

Non-small Cell Lung Cancer Metastatic Clinical Trial

— TAXIS01  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01356303
• Other study ID #: RC08/068
• Status: Suspended
• Phase: Phase 2
• First received: March 19, 2011
• Last updated: May 12, 2016
• Start date: March 2009
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: National Guard Health Affairs
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven non-small cell lung carcinoma

• Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.

• Patient should not be eligible for customization chemotherapy (if available at participating institutions).

• Having at least one measurable lesion

• Patient has life expectancy of 12 weeks or greater.

• Age > 18 years.

• No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given more than 1 year ago is acceptable.

• WHO performance status 0-2 (See Appendix III )

• Adequate organ function:

• Hematology: Neutrophils > 2 x 10 9 /L, platelets > 100 x 10 9 /L

• Hepatic function: Total bilirubin < 1.25 times the upper normal limits, ASAT (SGOT) < 2 times the upper normal limits

• Renal function: Creatinine < 1.5 mg/dL; if value is higher than upper normal limit but less than 2 mg/dL, the creatinine clearance should be > 60min/ml.

• Able to comply with scheduled follow-up and with management of toxicity

• Signed informed consent from patient or legal representative

• Negative urine pregnancy test (if indicated)

Exclusion Criteria:

• Pregnant or lactating women or women of childbearing potential using inadequate contraception.

• Uncontrolled brain metastatic disease. (CNS disease that is stable > 4 weeks after radiotherapy in lieu of steroids reduction is eligible).

• Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity Criteria Version 3

• Other serious illness or medical condition:

• Unstable cardiac disease requiring treatment

• History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures

• Active uncontrolled infection

• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening

• Concurrent treatment with any other anti-cancer therapy

• Contraindication of steroid drug administration

• Past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	King Abdul Aziz Medical City for National Guard Health Affairs	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
National Guard Health Affairs

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	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	3 years	Yes
Secondary	Progression free survival, safety	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	3 years	Yes