The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.

Detailed Description
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This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens: docetaxel docetaxel + vinorelbine docetaxel + gemcitabine docetaxel + capecitabine

Official Title
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Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer

Conditions
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Advanced Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: vinorelbine
* Drug: gemcitabine
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Age > 18 Histological diagnosis of non small-cell lung cancer (NSCLC) Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion) Disease in progression Previous chemotherapy with platinum-derivative (and with > 21 days from last administration) Exclusion Criteria: ECOG performance status > 2 Age > 75 years History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) Previous treatment with docetaxel Presence of symptomatic cerebral metastasis Neutrophils < 2.0 x 109/l, platelets < 100,000/l, hemoglobin > 10g/dl Bilirubin < 1.5 x the upper normal limit SGOT , SGPT, or bilirubin > 1.25 x the upper normal limits except in the presence of hepatic metastasis Creatinine >1.25 x the upper normal limit Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol Inability to comply with follow up Pregnant or nursing females

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: docetaxel<br>single agent docetaxel | Drug: docetaxel<br> <br> |
| Experimental: docetaxel + vinorelbine OR gemcitabine<br>docetaxel in combination with either vinorelbine or with gemcitabine | Drug: docetaxel<br> <br> Drug: vinorelbine<br> <br> Drug: gemcitabine<br> <br> |
| Experimental: docetaxel + capecitabine<br>docetaxel in combination with capecitabine | Drug: docetaxel<br> <br> Drug: capecitabine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second line, monochemotherapy, combination chemotherapy, platinum refractory, previously treated