Carcinoma, Small Cell, Lung Cancer
Conditions
Keywords
Extensive stage, Relapsed
Brief 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.
Detailed description
Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other cycle.
Interventions
DRUGVinflunine
320mg/m2 every 21 days as a 15-20 minute infusion
Sponsors
Bristol-Myers Squibb
SCRI Development Innovations, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 18 months | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease | 18 months | The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. |
| Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | 18 months | Overall survival was measured from the date of study entry until the date of death. |
| 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 | 18 months | Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vinflunine Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Vinflunine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age Continuous | 61 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 51 |
| serious Total, serious adverse events | 31 / 51 |
Outcome results
Primary
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
Time frame: 18 months
Population: All patients were assessed for response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vinflunine | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 19.6 percentage of participants |
Secondary
Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Time frame: 18 months
Population: All patients were assessed for response. Only patients with objective response were analyzed for response duration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vinflunine | Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease | 2.7 Months |
Secondary
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Overall survival was measured from the date of study entry until the date of death.
Time frame: 18 months
Population: All patients were assessed for overall survival.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vinflunine | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | 4.9 Months |
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
Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
Time frame: 18 months
Population: All patients were assessed for progression free survival.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vinflunine | 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 Months |