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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356303
Recruitment Status : Suspended (Difficulty in enrolling patients)
First Posted : May 19, 2011
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
National Guard Health Affairs

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Metastatic Drug: cisplatin, docetaxel Phase 2

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 3 years ]

    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

Secondary Outcome Measures :
  1. Progression free survival, safety [ Time Frame: 3 years ]
    • 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356303

Saudi Arabia
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, Saudi Arabia, 11426
Sponsors and Collaborators
National Guard Health Affairs
Principal Investigator: Abdulrahman Jazieh, MD/MPH King Abdul Aziz Medical City for National Guard

Responsible Party: National Guard Health Affairs Identifier: NCT01356303     History of Changes
Other Study ID Numbers: RC08/068
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by National Guard Health Affairs:
Lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action