Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)

May 20, 2013 updated by: Alaunos Therapeutics

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

548

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Carboplatin
AUC 5 mg/mL/min 1 day every 21 days for a max 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: Carboplatin
AUC 4 mg/mL/min 1 day 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.
Drug: Carboplatin
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Assessed every 12 weeks for survival until 1 year following completion of enrollment
Assessed every 12 weeks for survival until 1 year following completion of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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
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
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
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
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaunos Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 21, 2013

Last Update Submitted That Met QC Criteria

May 20, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM3002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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