Weekly Docetaxel and Four Weekly Carboplatin in Non-small Cell Lung Cancer Carbo-Tax

Study Overview
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Brief Summary
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The purpose of this study is: to assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time.

Official Title
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Phase II Trial of Weekly Docetaxel and Four Weekly Carboplatin Combination in the First-line Treatment of Advanced Non-small Cell Lung Cancer

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: docetaxel and carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer ECOG Performance Status is 0-2 At least one measurable lesion in two dimensions by means of CT scan No brain metastases No prior chemotherapy for this malignancy, Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours urine ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 2.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis) Exclusion Criteria: Concomitant use of another anti-cancer therapy Chemotherapy, radiotherapy or curative surgery Evidence of intracerebral metastasis Unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis. Presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years. Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used Social or psychological condition that render the patient inadequate for the follow-up of the study Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel and carboplatin|weekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy by response rate |  | After the 3rd cycle, 6th cycle and at every follow up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | At each visit | 
| Efficacy by time to progression |  | Until the progression of all patients | 
| Overall survival |  | At the end of the study |