Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer (TAXIS01)

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

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.

Study Overview

• Status: Suspended
• Conditions: Non-small Cell Lung Cancer Metastatic
• Intervention / Treatment: Drug: cisplatin, docetaxel

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • King Abdul Aziz Medical City for National Guard Health Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 EventsLaboratory AssessmentsVital SignsPhysical Examinations	3 years

Collaborators and Investigators

• Sponsor: National Guard Health Affairs
• Investigators: Principal Investigator: Abdulrahman Jazieh, MD/MPH, King Abdul Aziz Medical City for National Guard

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: March 19, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: RC08/068