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

NCT ID: NCT01356303

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2016-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

cisplatin, docetaxel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Guard Health Affairs

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdulrahman Jazieh, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

King Abdul Aziz Medical City for National Guard

Locations

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RC08/068

Identifier Type: -

Identifier Source: org_study_id