Trial record 2 of 2 for:    MATISSE

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 study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT01555710
First received: March 12, 2012
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Extensive-Stage Small Cell Lung Cancer
Drug: Carboplatin
Drug: Palifosfamide-tris
Drug: Etoposide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Assessed every 12 weeks for survival until 1 year following completion of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 548
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)
Arms Assigned Interventions
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.
Drug: Carboplatin
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.
Drug: Etoposide
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555710

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States, 35205
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Redwood Regional Oncology Group
Santa Rosa, California, United States, 95403
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Hematology Oncology Associates of the Treasure Coast
Port Sant Lucie, Florida, United States, 34952
United States, Georgia
Peachtree Hematology Oncology Consultants
Atlanta, Georgia, United States, 30318
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Medical and Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
Illinois Cancer Specialists
Niles, Illinois, United States, 60714-5905
United States, Indiana
Central Indiana Cancer Centers
Fishers, Indiana, United States, 46037
Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Indiana University
Indianapolis, Indiana, United States, 46202
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States, 47303
United States, Kansas
University of Kansas Hospital
Overland Park, Kansas, United States, 66210
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Louisiana
Medical Oncology, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States, 21701
United States, Michigan
Metro Health Cancer Center
Wyoming, Michigan, United States, 49519
United States, Minnesota
Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center
Morristown, New Jersey, United States, 07962
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
New York Oncology Hematology, PC
Albany, New York, United States, 12110-2188
Montefiore Medical Center
Bronx, New York, United States, 10461
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Dayton Cancer Center, Medical Oncology Hematology Associates
Dayton, Ohio, United States, 45429
United States, Pennsylvania
Medical Oncology Associates Of Wyoming Valley, PC
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29403
United States, Texas
Texas Oncology- Baylor, Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-Medical City Dallas
Dallas, Texas, United States, 75230-6899
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0565
Oncology Consultants, PA
Houston, Texas, United States, 77024
Texas Oncology, PA
Wichita Falls, Texas, United States, 76310-1610
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
United States, Virginia
Fairfax Northern Virginia Hematology-Oncology, PC
Fairfax, Virginia, United States, 22031
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Wisconsin Institutes for Medical Research
Madison, Wisconsin, United States, 53705
Australia, New South Wales
Southern Medical Day Oncology Care Centre
Wollongong, New South Wales, Australia, 2500
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Canada, Quebec
Hôpital Laval
Sainte Foy, Quebec, Canada, G1V 4G5
France
Centre François Baclesse
Caen, Basse-normandie, France, 14076
Centre Hospitalier Universitaire -Hôpital Morvan
Brest, Bretagne, France, 29200
Centre Hospitalier Universitaire, Hopital Bretonneau
Tours cedex 1, Centre, France, 97044
Hôpital du Cluzeau
Limoges, Limousin, Lorraine, France, 87042
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint Herblain, Pays de La Loire, France, 44805
Hôpital Saint Joseph
Marseille, Provence Alpes Cote D'azur, France, 13008
Centre Hospitalier Lyon Sud
Pierre Bénité, Rhone-alpes, France, 69495
Centre Paul Strauss
Strasbourg, France, 67085
Hungary
Debreceni Egyetem Orvos és Egészségtudományi Centrum
Debrecen, Hajdu-bihar, Hungary
Mátrai Gyógyintézet
Mátraháza, Heves, Hungary
Israel
Rambam Medical Center
Haifa, Israel
Hadassah Medical Organization, Ein Kerem
Jerusalem, Israel, 91120
Meir Hospital Sapir Medical Center
Kfar Saba, Israel
Western Gallilee Medical Center
Nahariya, Israel, 22100
Rabin Medical Center Beilinson Campus
Petah Tiqwa, Israel, 49100
Italy
Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milano, Italy, 20162
Presidio Ospedaliero S. Chiara
Trento, Italy, 38100
Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomorskie, Poland
Wojewódzkie Centrum Onkologii
Gdansk, Pomorskie, Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Szczecin, Zachodniopomorskie, Poland
Russian Federation
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
Ufa, Bashkortostan, Russian Federation, 450054
City Oncology Hospital # 62
Moscow Region, Moscow, Russian Federation, 143423
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Primorskiy, Russian Federation, 163045
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan, Tatarstan, Russian Federation
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
Chelaybinsk, Russian Federation, 454087
Ivanovo Regional Oncology Centre
Ivanovo, Russian Federation
Cancer Research Center n.a. N.N. Blokhin
Moscow, Russian Federation
GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary
Nizhny Novgorod, Russian Federation, 603081
State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
Saint Petersburg, Russian Federation, 194044
Saint-Petersburg State Medical University n. a. I. P. Pavlov
Saint-Petersburg, Russian Federation
State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"
Yaroslavl, Russian Federation, 150040
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
United Kingdom
Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LT
Sponsors and Collaborators
Ziopharm
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT01555710     History of Changes
Other Study ID Numbers: IPM3002
Study First Received: March 12, 2012
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
France: Institutional Ethical Committee
France: Ministry of Health
Germany: Ethics Commission
Germany: Ministry of Health
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
Italy: Ethics Committee
Italy: Ministry of Health
Ukraine: Ethics Committee
Ukraine: Ministry of Health
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health
Taiwan : Food and Drug Administration
Taiwan: Institutional Review Board
Israel: Ethics Commission
Israel: Ministry of Health
Hungary: Institutional Ethics Committee
Hungary: Ministry of Health, Social and Family Affairs

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide
Etoposide phosphate
Isophosphamide mustard
Ifosfamide
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on August 28, 2014