Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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 Docetaxel.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Carboplatin; Docetaxel

Criteria

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.