This proposed Phase II trial will investigate the combination of irinotecan and carboplatin followed by sunitinib in the first-line treatment of patients with extensive-stage SCLC.
Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. The irinotecan/carboplatin doses that will be used in this study have been used in two previous Phase II SCLC trials, and were found to be extremely well tolerated (Thompson et al. 2005; Spigel et al. 2007). Adding a novel, minimally toxic agent to this regimen may further enhance efficacy in this patient population without contributing to toxicity. This trial will evaluate the use of sunitinib following 6 cycles of treatment with chemotherapy in the treatment of SCLC. The trial will be performed under the leadership of SCRI, a community-based, multi-center, clinical trial organization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15
carboplatin AUC=4 on Day 1
sunitinib 25 mg orally (PO) daily after initial chemotherapy
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Hospital Cancer Insitute
Orlando, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment
Time frame: 18 months
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.
Time frame: 18 months
Time to Progression
Time To Progression (TTP) was defined as the interval between the start date of treatment and the date of occurrence of progressive disease
Time frame: 18 months
Median Overall Survival
Overall survival was defined as the interval between the date of study entry until the date of death.
Time frame: 18 months
Number of Participants Experiencing Treatment Related Toxicity
The toxicity assessments were made according to the common terminology criteria for adverse events (CTCAE version 3.0) of the National Cancer Institute. Number of participants with Grade 1 to 5 adverse events are reported here.
Time frame: 18 months
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Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
St. Louis Cancer Care
Chesterfield, Missouri, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States