Carcinoma, Small Cell
Conditions
Keywords
Lung Cancer, Carcinoma, Small Cell
Brief summary
This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.
Detailed description
Eligible patients will receive treatment with carboplatin and topotecan. Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . \- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
Interventions
DRUGTopotecan
Topotecan 4mg/m2 IV on days 1, 8.
DRUGcarboplatin
Carboplatin AUC=5 IV day 1 only .
Sponsors
GlaxoSmithKline
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
* Patients must have confirmed small cell lung cancer with extensive stage disease. This includes patients with stage IIIB and IV disease. * Patients with small cell histology are eligible. Large neuroendocrine or mixed small cell and non-small cell histology are not eligible. * Patients must have measurable or evaluable disease. * ECOG performance status 0 or 1. * Patients must have adequate bone marrow, liver and kidney function * The patients may have had no previous chemotherapy. * Patients must be able to understand the nature of the study and give written informed consent.
Exclusion criteria
* Patients with limited stage disease. This includes IA, IB, IIA, IIB, and IIIA. * Age \< 18 years old. * History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma or stage A/B prostate cancer. * Female patients who are pregnant or are breast feeding * History of acute myocardial infarction or stroke within 6 months. * Uncontrolled hypertension, unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease. * Patients who have received other investigational drugs within 28 days. * Patients with CNS involvement (brain or meningeal). The single exception to this is the patient previously treated for brain metastases with radiation therapy, or surgical excision who has no evidence of active residual metastases on brain MRI at the time of study entry. * Patients with large neuroendocrine tumor or mixed small cell and non-small cell histology
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 percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. 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 category assigned represented the best response obtained during treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | 18 months | Time to progression is defined as the interval between the start date of treatment and the date of occurrence 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topotecan/Carboplatin Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.) | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | Topotecan/Carboplatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age Continuous | 66 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 61 |
| serious Total, serious adverse events | 28 / 61 |
Outcome results
Primary
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. 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 category assigned represented the best response obtained during treatment.
Time frame: 18 months
Population: All patients were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topotecan/Carboplatin | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 57 percentage of participants |
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) |
|---|---|---|
| Topotecan/Carboplatin | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | 8.5 Months |
Secondary
Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.
Time frame: 18 months
Population: All patients were assessed for time to progression.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topotecan/Carboplatin | Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | 5.5 Months |