Clinical trial · Interventional
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
- 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)
This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.
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 |
|---|---|---|---|
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Topotecan
- interventionNames
- Drug: Topotecan
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 18 months
Secondary outcomes (4)
- measure
- overall toxicity
- timeFrame
- 18 months
- measure
- time to progression
- timeFrame
- 18 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen * Measurable or evaluable disease * Able to perform activities of daily living with minimal assistance * Adequate bone marrow, liver and kidney function * May have received no more than 3 previous courses of radiation therapy * Give written informed consent prior to study entry Exclusion Criteria: * Patients with limited stage disease * History of a prior malignancy within three years * Female patients who are pregnant or are breast feeding * Significant history of uncontrolled cardiac disease * Myocardial infarction or stroke within six months * Symptomatic peripheral vascular disease * CNS involvement * Serious active infection or underlying medical condition
References
Publications (1)
- DERIVEDSpigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28. PMID 21663862