Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
NCT ID: NCT00315211
Last Updated: 2018-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2004-11-30
2007-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
* To determine the feasibility and toxicity of the combination of topotecan and docetaxel.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
NCT00087048
Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
NCT00003281
Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
NCT00305942
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
NCT00294190
Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
NCT00397293
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Weekly intravenous topotecan with intravenous docetaxel
Intravenous Topotecan
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Intravenous Docetaxel
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 \& 8 of a 21 day cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intravenous Topotecan
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Intravenous Docetaxel
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 \& 8 of a 21 day cycle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 1 measurable lesion
* Only 1 prior chemotherapy
* Must be over 18 years of age
* ECOG performance status of 0 - 2
* Adequate hematologic, renal, and hepatic function
Exclusion Criteria
* No symptomatic brain metastases
* History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
* No prior investigational agents within 1 month prior
* Lung cancer of mixed histology
* Known uncontrolled seizure disorders
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Aultman Health Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raza Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Aultman Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aultman Hospital
Canton, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lung 01
Identifier Type: OTHER
Identifier Source: secondary_id
Hycamtin study #102143
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.