Oral Topotecan Versus Intravenous Docetaxel In Pretreated, 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 collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).

Official Title
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An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: topotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Patients with advanced non-small cell lung cancer (NSCLC). Patients who have received one previous chemotherapy for NSCLC. Full recovery from previous chemotherapy. Presence of either measurable or non-measurable disease by radiologic study or physical examination. At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient). At least 24 hours since prior radiotherapy providing that marked bone marrow suppression is NOT expected. Patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting). Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function. Exclusion Criteria: Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids. Active infection. Severe medical problems other than the diagnosis of NSCLC, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk. Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC. Use of investigational drug within 30 days prior to the first dose of study medication. Women who are pregnant or lactating. Patients of child-bearing potential refusing to practice adequate birth control methods. Patients with conditions which might alter absorption of an oral drug.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Drug: topotecan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year survival rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival, time to progression, response rate, response duration, time to response, improvement in quality of life and patient well-being, and qualitative and quantitative toxicities. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonsmall Cell Lung cancer, advanced, Second-line, topotecan, Hycamtin, oral, docetaxel