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

This study has suspended participant recruitment.
(Difficulty in enrolling patients)
Sponsor:
Information provided by (Responsible Party):
National Guard Health Affairs
ClinicalTrials.gov Identifier:
NCT01356303
First received: March 19, 2011
Last updated: May 12, 2016
Last verified: May 2016
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer Metastatic
Drug: cisplatin, docetaxel
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Guard Health Affairs:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356303

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

Responsible Party: National Guard Health Affairs
ClinicalTrials.gov Identifier: NCT01356303     History of Changes
Other Study ID Numbers: RC08/068 
Study First Received: March 19, 2011
Last Updated: May 12, 2016
Health Authority: Saudi Arabia: Ethics Committee

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2016