Clinical trial NCT01555710: Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Extensive-Stage Small Cell Lung Cancer
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Assessed every 12 weeks for survival until 1 year following completion of enrollment
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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)
measure: Quality of Life (QOL) as assessed by EQ-5D-3L and QLQ-LC13
timeFrame: Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled
measure: Objective Response Rate (ORR)
timeFrame: Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed
measure: Response Duration
timeFrame: 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
measure: 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
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates, LLC
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Oncology Group
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Port Sant Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology Oncology Consultants
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Galesburg
country: United States
facility: Medical and Surgical Specialists, LLC
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Fishers
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hospital
state: Indiana
city: Overland Park
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Baton Rouge
country: United States
facility: Medical Oncology, LLC
state: Louisiana
city: Frederick
country: United States
facility: Frederick Memorial Hospital Regional Cancer Therapy Center
state: Maryland
city: Wyoming
country: United States
facility: Metro Health Cancer Center
state: Michigan
city: Duluth
country: United States
facility: Saint Mary's Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Dayton
country: United States
facility: Dayton Cancer Center, Medical Oncology Hematology Associates
state: Ohio
city: Kingston
country: United States
facility: Medical Oncology Associates Of Wyoming Valley, PC
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology-Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Baylor, Charles A. Sammons Cancer Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, PA
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology, PA
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology-Oncology, PC
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Madison
country: United States
facility: Wisconsin Institutes for Medical Research
state: Wisconsin
city: Wollongong
country: Australia
facility: Southern Medical Day Oncology Care Centre
state: New South Wales
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Oshawa
country: Canada
facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
state: Ontario
city: Sainte Foy
country: Canada
facility: Hôpital Laval
state: Quebec
city: Caen
country: France
facility: Centre François Baclesse
state: Basse-normandie
city: Brest
country: France
facility: Centre Hospitalier Universitaire -Hôpital Morvan
state: Bretagne
city: Tours cedex 1
country: France
facility: Centre Hospitalier Universitaire, Hopital Bretonneau
state: Centre
city: Limoges
country: France
facility: Hôpital du Cluzeau
state: Limousin, Lorraine
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - René Gauducheau
state: Pays de La Loire
city: Marseille
country: France
facility: Hôpital Saint Joseph
state: Provence Alpes Cote D'azur
city: Pierre Bénité
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone-alpes
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum
state: Hajdu-bihar
city: Mátraháza
country: Hungary
facility: Mátrai Gyógyintézet
state: Heves
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Ein Kerem
city: Kfar Saba
country: Israel
facility: Meir Hospital Sapir Medical Center
city: Nahariya
country: Israel
facility: Western Gallilee Medical Center
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda
city: Trento
country: Italy
facility: Presidio Ospedaliero S. Chiara
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Gdansk
country: Poland
facility: Wojewódzkie Centrum Onkologii
state: Pomorskie
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego
state: Zachodniopomorskie
city: Ufa
country: Russian Federation
facility: Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
state: Bashkortostan
city: Moscow Region
country: Russian Federation
facility: City Oncology Hospital # 62
state: Moscow
city: Arkhangelsk
country: Russian Federation
facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
state: Primorskiy
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
state: Tatarstan
city: Chelaybinsk
country: Russian Federation
facility: State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Centre
city: Moscow
country: Russian Federation
facility: Cancer Research Center n.a. N.N. Blokhin
city: Nizhny Novgorod
country: Russian Federation
facility: GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical University n. a. I. P. Pavlov
city: Yaroslavl
country: Russian Federation
facility: State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: England
Study officials:
References: