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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Docetaxel + Carboplatin | Drug: Docetaxel<br>* Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles<br>* Other names: Taxotere;Drug: Carboplatin<br>* Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15<br>|
| Experimental: 2<br>Docetaxel | Drug: Docetaxel<br>* Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the overall survival between the two treatment groups |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the objective response rates between the two treatment groups |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | 
| Evaluation and comparison of the toxicity between the two treatment groups |  | Toxicity assessment on each chemotherapy cycle | 
| Measurement and comparison of the health-related quality of life of patients on both treatment groups |  | Assessment every two cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, 2nd line chemotherapy, Docetaxel