Clinical trial · Interventional
Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC
Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)
NCT00697476CI-TRIAL-00010447terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient enrollment
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the maximum tolerated dose, the activity and the safety profile of the combination of vorinostat and topotecan in patients with recurrent small cell lung cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan, vorinostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat/Topotecan
- description
- Vorinostat/topotecan dose escalation regimen. vorinostat is administered orally once a day for 7 to 14 consecutive days, according to the dose level.Topotecan is administered I.V. for 5 consecutive days every three weeks. Vorinostat dose levels go from 300 mg/day for 7 days to 400 mg/day for 14 days. Topotecan dose levels go from 1,2 mg/m2 to 1,5 mg/m2
- interventionNames
- Drug: topotecan, vorinostat
Primary outcomes (1)
- measure
- Maximum tolerated dose of the combination as the recommended dose for phase II trial [Phase I]; objective response rate of the combination [Phase II]; toxicity and safety profile of the combination [Phase II]
- timeFrame
- Limiting tolerated dose (Phase I); efficacy/toxicity after the inclusion of the last patient (Phase II)
Secondary outcomes (1)
- measure
- To assess the antitumor activity of the combination in terms of time to progression (TTP) and overall survival (OS) [Phase II]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven diagnosis of SCLC; * Limited or extensive-stage disease in patients who have received a single chemotherapy regimen or combined modality (chemotherapy + chest radiotherapy) regimen and relapsed after completion of first-line chemotherapy (sensitive relapse); * Age \>/= 18 years; * ECOG Performance Status 0-2; * Life expectancy of at least 12 weeks; * Measurable lesions according to RECIST criteria; * Adequate cardiac, hepatic, renal, and bone marrow function; * Written informed consent. Exclusion Criteria: * Prior treatment with an HDAC inhibitor; * Symptomatic and/or unstable pre-existing brain metastases; * Superior Vena Cava Syndrome; * Spinal cord compression; * Severe or uncontrolled medical diseases (Hypertension, diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, or active uncontrolled infections); * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ; * Pregnant or breastfeeding women.
References
Publications (0)
Data not yet available
No reference posted for this study.