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

Hellenic Oncology Research Group

Status and phase

Completed

Phase 3

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Carboplatin

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00430651

CT/04.14

Details and patient eligibility

About

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.

Enrollment

135 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.