Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00049998
• Date of registration: 18/11/2002
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
• Scientific title: An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
• Date of first enrolment: October 2001
• Target sample size: 760
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00049998
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom

Contacts

• Name: GSK Clinical Trials, MD
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-Small-Cell Lung Cancer

Intervention(s)

Drug: topotecan

Primary Outcome(s)

One-year survival rate

Secondary Outcome(s)

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.

Secondary ID(s)

104864-A/387

Source(s) of Monetary Support

Please refer to primary and secondary sponsors