Clinical trial · Interventional
Topotecan for Irinotecan-Refractory SCLC
Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer
NCT00502762CI-TRIAL-00001337unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Refractory to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (1)
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.