Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
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.
Extensive-Stage Small Cell Lung Cancer
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study|
- 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 ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Palifosfamide-tris plus Carboplatin and Etoposide
Drug: palifosfamide-tris in combination with carboplatin and etoposide palifosfamide-tris: 130 mg/m2/day 3 days every 21 days for a max of 6 cycles. carboplatin: AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a max of 6 cycles.
AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.Drug: Palifosfamide-tris
130 mg/m2/day 3 days every 21 days for a max of 6 cycles.Drug: Etoposide
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Active Comparator: Carboplatin plus Etoposide
Drug: carboplatin in combination with etoposide carboplatin: AUC 5mg/mL/min 1 day every 21 days for a maximum of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.Drug: Carboplatin
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555710
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