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Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).


Phase 3
18 Years
75 Years
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).


Inclusion Criteria:



- Histologically or cytologically confirmed NSCLC.

- ECOG Performance Status 0-2.

- No previous treatment with Docetaxel.

- Measurable Disease.

- Brain metastases that have been treated with radiotherapy should be stable and
asymptomatic.

- Adequate liver kidney and bone marrow function.

- Patients must be able to understand the nature of this study and give written
informed consent.

Exclusion Criteria:

- Active cardiac disease: unstable angina or onset of angina within last 3 months,
myocardial infarction within 6 months, congestive heart failure > class II, cardiac
ventricular arrhythmias requiring anti-arrhythmic therapy.

- Women who are pregnant or lactating.

- Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.

- Serious neurologic or psychiatric disease.

- Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or
in situ carcinoma of the cervix.

- Active uncontrolled infection.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the overall survival between the two treatment groups

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Vassilis Georgoulias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/04.14

NCT ID:

NCT00430651

Start Date:

July 2004

Completion Date:

May 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • 2nd line chemotherapy
  • Docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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