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 trial is active, not recruiting.
|Condition||extensive-stage small cell lung cancer|
|Treatments||carboplatin, palifosfamide-tris, etoposide|
|Start date||May 2012|
|End date||June 2015|
|Trial size||548 participants|
|Trial identifier||NCT01555710, IPM3002|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||Birmingham Hematology and Oncology Associates, LLC||no longer recruiting|
|Los Angeles, CA||University of Southern California||no longer recruiting|
|Santa Rosa, CA||Redwood Regional Oncology Group||no longer recruiting|
|Newark, DE||Christiana Care Health Services||no longer recruiting|
|Jacksonville, FL||Baptist Cancer Institute||no longer recruiting|
|Port Sant Lucie, FL||Hematology Oncology Associates of the Treasure Coast||no longer recruiting|
|Atlanta, GA||Peachtree Hematology Oncology Consultants||no longer recruiting|
|Chicago, IL||Rush University Medical Center||no longer recruiting|
|Galesburg, IL||Medical and Surgical Specialists, LLC||no longer recruiting|
|Niles, IL||Illinois Cancer Specialists||no longer recruiting|
|Fishers, IN||Central Indiana Cancer Centers||no longer recruiting|
|Goshen, IN||Goshen Center for Cancer Care||no longer recruiting|
|Indianapolis, IN||Indiana University||no longer recruiting|
|Lafayette, IN||Horizon Oncology Center||no longer recruiting|
|Muncie, IN||Indiana University Health Ball Memorial Hospital||no longer recruiting|
|Overland Park, KS||University of Kansas Hospital||no longer recruiting|
|Lexington, KY||Central Baptist Hospital||no longer recruiting|
|Baton Rouge, LA||Medical Oncology, LLC||no longer recruiting|
|Frederick, MD||Frederick Memorial Hospital Regional Cancer Therapy Center||no longer recruiting|
|Wyoming, MI||Metro Health Cancer Center||no longer recruiting|
|Duluth, MN||Saint Mary's Medical Center||no longer recruiting|
|Minneapolis, MN||Virginia Piper Cancer Institute||no longer recruiting|
|Hackensack, NJ||John Theurer Cancer Center at Hackensack University Medical Center||no longer recruiting|
|Morristown, NJ||Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center||no longer recruiting|
|Albuquerque, NM||University of New Mexico Cancer Center||no longer recruiting|
|Albany, NY||New York Oncology Hematology, PC||no longer recruiting|
|Bronx, NY||Montefiore Medical Center||no longer recruiting|
|Cincinnati, OH||The Christ Hospital||no longer recruiting|
|Dayton, OH||Dayton Cancer Center, Medical Oncology Hematology Associates||no longer recruiting|
|Kingston, PA||Medical Oncology Associates Of Wyoming Valley, PC||no longer recruiting|
|Charleston, SC||Charleston Hematology Oncology Associates, PA||no longer recruiting|
|Dallas, TX||Texas Oncology- Baylor, Charles A. Sammons Cancer Center||no longer recruiting|
|Dallas, TX||Texas Oncology-Medical City Dallas||no longer recruiting|
|Galveston, TX||University of Texas Medical Branch at Galveston||no longer recruiting|
|Houston, TX||Oncology Consultants, PA||no longer recruiting|
|Wichita Falls, TX||Texas Oncology, PA||no longer recruiting|
|Burlington, VT||Fletcher Allen Health Care||no longer recruiting|
|Fairfax, VA||Fairfax Northern Virginia Hematology-Oncology, PC||no longer recruiting|
|Seattle, WA||Swedish Medical Center||no longer recruiting|
|Madison, WI||Wisconsin Institutes for Medical Research||no longer recruiting|
|Wollongong, Australia||Southern Medical Day Oncology Care Centre||no longer recruiting|
|Winnipeg, Canada||CancerCare Manitoba||no longer recruiting|
|Oshawa, Canada||R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa||no longer recruiting|
|Sainte Foy, Canada||Hôpital Laval||no longer recruiting|
|Caen, France||Centre François Baclesse||no longer recruiting|
|Brest, France||Centre Hospitalier Universitaire -Hôpital Morvan||no longer recruiting|
|Tours cedex 1, France||Centre Hospitalier Universitaire, Hopital Bretonneau||no longer recruiting|
|Limoges, France||Hôpital du Cluzeau||no longer recruiting|
|Saint Herblain, France||Institut de Cancérologie de l'Ouest - René Gauducheau||no longer recruiting|
|Marseille, France||Hôpital Saint Joseph||no longer recruiting|
|Pierre Bénité, France||Centre Hospitalier Lyon Sud||no longer recruiting|
|Strasbourg, France||Centre Paul Strauss||no longer recruiting|
|Debrecen, Hungary||Debreceni Egyetem Orvos és Egészségtudományi Centrum||no longer recruiting|
|Mátraháza, Hungary||Mátrai Gyógyintézet||no longer recruiting|
|Haifa, Israel||Rambam Medical Center||no longer recruiting|
|Jerusalem, Israel||Hadassah Medical Organization, Ein Kerem||no longer recruiting|
|Kfar Saba, Israel||Meir Hospital Sapir Medical Center||no longer recruiting|
|Nahariya, Israel||Western Gallilee Medical Center||no longer recruiting|
|Petah Tiqwa, Israel||Rabin Medical Center Beilinson Campus||no longer recruiting|
|Genova, Italy||Istituto Nazionale per la Ricerca sul Cancro||no longer recruiting|
|Milano, Italy||Azienda Ospedaliera Ospedale Niguarda Ca' Granda||no longer recruiting|
|Trento, Italy||Presidio Ospedaliero S. Chiara||no longer recruiting|
|Warszawa, Poland||Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie||no longer recruiting|
|Gdansk, Poland||Uniwersyteckie Centrum Kliniczne||no longer recruiting|
|Gdansk, Poland||Wojewódzkie Centrum Onkologii||no longer recruiting|
|Szczecin, Poland||Specjalistyczny Szpital im. Alfreda Sokolowskiego||no longer recruiting|
|Ufa, Russian Federation||Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan||no longer recruiting|
|Moscow Region, Russian Federation||City Oncology Hospital # 62||no longer recruiting|
|Arkhangelsk, Russian Federation||State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"||no longer recruiting|
|Kazan, Russian Federation||Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan||no longer recruiting|
|Chelaybinsk, Russian Federation||State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"||no longer recruiting|
|Ivanovo, Russian Federation||Ivanovo Regional Oncology Centre||no longer recruiting|
|Moscow, Russian Federation||Cancer Research Center n.a. N.N. Blokhin||no longer recruiting|
|Nizhny Novgorod, Russian Federation||GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary||no longer recruiting|
|Saint Petersburg, Russian Federation||State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"||no longer recruiting|
|Saint-Petersburg, Russian Federation||Saint-Petersburg State Medical University n. a. I. P. Pavlov||no longer recruiting|
|Yaroslavl, Russian Federation||State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"||no longer recruiting|
|Taichung, Taiwan||China Medical University Hospital||no longer recruiting|
|Manchester, United Kingdom||Wythenshawe Hospital||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
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
Male or female participants at least 18 years old.
- Documented extensive-stage small cell lung cancer.
- Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer.
- ECOG Performance Status of 0, 1 or 2.
- Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests.
- Male and female patients must agree to use a highly reliable method of birth control during study participation.
- Able to provide informed consent
- Previously untreated (non-irradiated), symptomatic brain metastases.
- Known allergy to any of the study drugs or their excipients.
- Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
- Any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (Exception: Subjects with a history of malignancy other than small cell lung cancer may be enrolled after consultation with the medical monitor provided the patient's prognosis is best defined by the extensive-stage small cell lung cancer).
- Currently pregnant or nursing.
|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|
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