Topotecan for Irinotecan-Refractory SCLC
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer|
- Response rate
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||August 2007|
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).
Please refer to this study by its ClinicalTrials.gov identifier: 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|