An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
- 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
- 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.
- Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment
- 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
- 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
- Women who are pregnant or lactating.
- Patients of child-bearing potential refusing to practice adequate birth control
- Patients with conditions which might alter absorption of an oral drug.