Phase 2
Completed N=51
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Carcinoma, Small Cell · Lung Cancer
Source: ClinicalTrials.gov NCT00284154 ↗
Enrolled (actual)
51
Serious AEs
60.8%
Results posted
Mar 2013
Primary outcomePrimary: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment — 19.6 percentage of participants
Summary
This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
19.6 | — |
| SECONDARY Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease |
2.7 | — |
| SECONDARY Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
4.9 | — |
| SECONDARY Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease |
1.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 hematological, liver, and kidney function
- Must give written informed consent prior to entry
Exclusion Criteria
- CNS involvement
- Serious active infection or underlying medical condition
- Significant history of uncontrolled cardiac disease
Data sourced from ClinicalTrials.gov (NCT00284154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.