Status:
COMPLETED
Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Do...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00430651
Start Date
July 1 2004
End Date
May 1 2008
Last Update
January 28 2009
Active Locations (10)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece