Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502762
Status:
UNKNOWN
Last Update Posted:
2008-03-12
First Post:
2007-07-16
Brief Title:
Topotecan for Irinotecan-Refractory SCLC
Sponsor:
Gachon University Gil Medical Center
Organization:
Gachon University Gil Medical Center
Study Overview
Official Title:
Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently demonstrated in phase IIIII clinical trials the choice of irinotecan as first-line therapy prevented use of the evidence-based option
This pilot study will be conducted to determine the activity and safety of topotecan in SCLC patients refractory to first-line therapy with irinotecan and platinum
This pilot study will be conducted to determine the activity and safety of topotecan in SCLC patients refractory to first-line therapy with irinotecan and platinum
Detailed Description:
Current commonly used second-line approaches for SCLC include re-induction with first-line therapy for chemosensitive disease or single-agent topotecan Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently demonstrated in a number of clinical studies the choice of irinotecan as first-line therapy prevented use of the evidence-based option such as topotecan Topotecan and irinotecan are cytotoxic agents that inhibit same intracellular pathway namely topoisomerase I which is an enzyme involved in DNA replication and RNA transcription
Although their mechanism of action is similar the preclinical and clinical data of these two drugs have some notable differences Topotecan and irinotecan have different spectra of antitumor activity in various models of human cancer Clinical data support that these agents may have different spectra of activity The differences in antitumor activities may also reflect different mechanisms of resistance Furthermore topotecan and irinotecan have different limiting toxicities myelosuppression and diarrhea respectively
Although their mechanism of action is similar the preclinical and clinical data of these two drugs have some notable differences Topotecan and irinotecan have different spectra of antitumor activity in various models of human cancer Clinical data support that these agents may have different spectra of activity The differences in antitumor activities may also reflect different mechanisms of resistance Furthermore topotecan and irinotecan have different limiting toxicities myelosuppression and diarrhea respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None