A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer
- To examine the anti-tumor efficacy of the combination of Irinotecan (CPT-11) and
Carboplatin as first-line therapy as assessed by response rate in patients with
chemo-naïve extensive stage small cell lung cancer.
- Determine the safety, tolerability, and feasibility of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open-label study.
Patients receive irinotecan IV over 30-90 minutes on days 1 and 8 and carboplatin IV on day
1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient response to treatment: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
1.66 months (average duration, on treatment date to best response date)
Leora Horn, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC THO 0321
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|MBCCOP - Meharry Medical College - Nashville||Nashville, Tennessee 37208-3599|
|West Tennessee Cancer Center at Jackson-Madison County General Hospital||Jackson, Tennessee 38301|
|Owensboro Medical Health System||Owensboro, Kentucky 42303|
|Memorial Health Care System||Chattanooga, Tennessee 37404|
|Tennessee Cancer Specialists||Knoxville, Tennessee 37920|
|St. Thomas Health Services||Nashville, Tennessee 37205|