This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
548
AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.
130 mg/m2/day 3 days every 21 days for a max of 6 cycles.
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
Redwood Regional Oncology Group
Santa Rosa, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Overall Survival (OS)
Time frame: Assessed every 12 weeks for survival until 1 year following completion of enrollment
Progression Free Survival (PFS)
Time frame: Assessed every 6 weeks for 22 weeks, then every 12 weeks until progressive disease, initiation of alternate anticancer therapy, or 1 year following the last patient enrolled (whichever is soonest)
Quality of Life (QOL) as assessed by EQ-5D-3L and QLQ-LC13
Time frame: Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled
Objective Response Rate (ORR)
Time frame: Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed
Response Duration
Time frame: Time from the date of first objective response (partial or complete response), with subsequent confirmation, until the date of disease progression or the occurrence of death
Safety parameters (number of adverse events as well as number of findings from physical examinations, ECGs, vital signs, and clinical laboratory results)using NCI CTCAE v. 4.03
Time frame: 22 weeks
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