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

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer Metastatic

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Trial Information

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

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

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Abdulrahman Jazieh, MD/MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Abdul Aziz Medical City for National Guard


Saudi Arabia: Ethics Committee

Study ID:




Start Date:

March 2009

Completion Date:

February 2013

Related Keywords:

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