Topotecan for Irinotecan-Refractory SCLC
|ClinicalTrials.gov Identifier: NCT00502762|
Recruitment Status : Unknown
Verified March 2008 by Gachon University Gil Medical Center.
Recruitment status was: Active, not recruiting
First Posted : July 18, 2007
Last Update Posted : March 12, 2008
Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently demonstrated in phase II/III 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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Refractory to Chemotherapy||Drug: topotecan||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer|
|Study Start Date :||September 2004|
|Estimated Study Completion Date :||August 2007|
- Response rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502762
|Korea, Republic of|
|Gachon University Gil Medical Center|
|Incheon, Korea, Republic of, 405 760|
|Principal Investigator:||Eun Kyung Cho, MD||Gachon University Gil Medical Center, Incheon, Korea|