Overview

This trial is active, not recruiting.

Conditions lung cancer, refractory to chemotherapy
Treatment topotecan
Phase phase 2
Sponsor Gachon University Gil Medical Center
Start date September 2004
End date August 2007
Trial identifier NCT00502762, GMO-LU-51

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response rate
time frame:

Secondary Outcomes

Measure
Safety
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - histologically or cytologically proven SCLC - refractory to prior irinotecan-based chemotherapy - Eastern Cooperative Oncology Group (ECOG) performance status ≤2 - age between 18 and 75 years - no active brain or leptomeningeal metastases - adequate hematologic, hepatic and renal functions - at least one measurable lesion(s) Exclusion Criteria: - pregnant or lactating women - patients with active infection - extensive radiotherapy within the previous 4 weeks - previous other malignancies with the exception of adequately treated non-melanoma skin cancer or in situ cervical cancer - any severe comorbid illness - a known history of anaphylaxis of any origin - history of severe adverse events to the drug used in this study

Additional Information

Official title Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer
Principal investigator Eun Kyung Cho, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Gachon University Gil Medical Center.