Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00315211|
Recruitment Status : Terminated (Slow Accrual)
First Posted : April 18, 2006
Last Update Posted : August 20, 2018
The purposes of this study are:
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Mediastinal Neoplasms||Drug: Intravenous Topotecan Drug: Intravenous Docetaxel||Phase 2|
The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||November 8, 2007|
Weekly intravenous topotecan with intravenous docetaxel
Drug: Intravenous Topotecan
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Other Name: Hycamtin
Drug: Intravenous Docetaxel
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
Other Name: Taxotere
- To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel [ Time Frame: 3 years ]To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315211
|United States, Ohio|
|Canton, Ohio, United States, 44710|
|Principal Investigator:||Raza Khan, MD||Aultman Hospital|