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

• ClinicalTrials.gov Identifier: NCT00049998
• Recruitment Status: Completed
• First Posted: November 20, 2002
• Last Update Posted: March 4, 2013
• Sponsor: GlaxoSmithKline
• Information provided by: GlaxoSmithKline

Tracking Information

• First Submitted Date: November 18, 2002
• First Posted Date: November 20, 2002
• Last Update Posted Date: March 4, 2013
• Study Start Date: October 2001
• Actual Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 8, 2006): One-year survival rate
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: March 8, 2006): 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.
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
• Official 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
• Brief Summary: 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small-Cell Lung Cancer
• Intervention: Drug: topotecan
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: March 8, 2006): 760
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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

Administrative Information

• NCT Number: NCT00049998
• Other Study ID Numbers: 104864-A/387
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Study Director, GSK
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials, MD; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: March 2013