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

NCT01555710 | Unknown Phase 3 DMC

• 1 other identifier: IPM3002
• Study Type: interventional
• Target: 548
• Locations: 11 countries
• Sites: 79

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.

Conditions

Extensive-Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Assessed every 12 weeks for survival until 1 year following completion of enrollment

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  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

  Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled

• Objective Response Rate (ORR)

  Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed

• Response Duration

  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

  22 weeks

Study Arms (2)

Palifosfamide-tris plus Carboplatin and Etoposide

EXPERIMENTAL

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; Drug: Palifosfamide-tris; Drug: Etoposide

Carboplatin plus Etoposide

ACTIVE COMPARATOR

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; Drug: Carboplatin

Interventions

Carboplatin DRUG

AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.

Palifosfamide-tris plus Carboplatin and Etoposide

Palifosfamide-tris DRUG

130 mg/m2/day 3 days every 21 days for a max of 6 cycles.

Palifosfamide-tris plus Carboplatin and Etoposide

Etoposide DRUG

100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.

Carboplatin plus Etoposide; Palifosfamide-tris plus Carboplatin and Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (79)

Birmingham Hematology and Oncology Associates, LLC

Birmingham, Alabama, 35205, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Redwood Regional Oncology Group

Santa Rosa, California, 95403, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Sant Lucie, Florida, 34952, United States

Location

Peachtree Hematology Oncology Consultants

Atlanta, Georgia, 30318, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Medical and Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714-5905, United States

Location

Central Indiana Cancer Centers

Fishers, Indiana, 46037, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Indiana University Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

University of Kansas Hospital

Overland Park, Kansas, 66210, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Medical Oncology, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Frederick Memorial Hospital Regional Cancer Therapy Center

Frederick, Maryland, 21701, United States

Location

Metro Health Cancer Center

Wyoming, Michigan, 49519, United States

Location

Saint Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center

Morristown, New Jersey, 07962, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

New York Oncology Hematology, PC

Albany, New York, 12110-2188, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Dayton Cancer Center, Medical Oncology Hematology Associates

Dayton, Ohio, 45429, United States

Location

Medical Oncology Associates Of Wyoming Valley, PC

Kingston, Pennsylvania, 18704, United States

Location

Charleston Hematology Oncology Associates, PA

Charleston, South Carolina, 29403, United States

Location

Texas Oncology-Medical City Dallas

Dallas, Texas, 75230-6899, United States

Location

Texas Oncology- Baylor, Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0565, United States

Location

Oncology Consultants, PA

Houston, Texas, 77024, United States

Location

Texas Oncology, PA

Wichita Falls, Texas, 76310-1610, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

Fairfax Northern Virginia Hematology-Oncology, PC

Fairfax, Virginia, 22031, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Wisconsin Institutes for Medical Research

Madison, Wisconsin, 53705, United States

Location

Southern Medical Day Oncology Care Centre

Wollongong, New South Wales, 2500, Australia

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Hôpital Laval

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Centre Hospitalier Lyon Sud

Pierre Bénité, Auvergne-Rhône-Alpes, 69495, France

Location

Centre François Baclesse

Caen, Basse-normandie, 14076, France

Location

Centre Hospitalier Universitaire -Hôpital Morvan

Brest, Brittany Region, 29200, France

Location

Centre Hospitalier Universitaire, Hopital Bretonneau

Tours, Centre-Val de Loire, 97044, France

Location

Hôpital du Cluzeau

Limoges, Limousin, Lorraine, 87042, France

Location

Institut de Cancérologie de l'Ouest - René Gauducheau

Saint-Herblain, Pays de la Loire Region, 44805, France

Location

Hôpital Saint Joseph

Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Debreceni Egyetem Orvos és Egészségtudományi Centrum

Debrecen, Hajdú-Bihar, Hungary

Location

Mátrai Gyógyintézet

Mátraháza, Heves County, Hungary

Location

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medical Organization, Ein Kerem

Jerusalem, 91120, Israel

Location

Meir Hospital Sapir Medical Center

Kfar Saba, Israel

Location

Western Gallilee Medical Center

Nahariya, 22100, Israel

Location

Rabin Medical Center Beilinson Campus

Petah Tikva, 49100, Israel

Location

Istituto Nazionale per la Ricerca sul Cancro

Genova, Genova, Italy

Location

Presidio Ospedaliero S. Chiara

Trento, Trento, 38100, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

Location

Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie

Warsaw, Masovian Voivodeship, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Location

Wojewódzkie Centrum Onkologii

Gdansk, Pomeranian Voivodeship, Poland

Location

Specjalistyczny Szpital im. Alfreda Sokolowskiego

Szczecin, West Pomeranian Voivodeship, Poland

Location

Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan

Ufa, Bashkortostan Republic, 450054, Russia

Location

Ivanovo Regional Oncology Centre

Ivanovo, Ivanovo Oblast, Russia

Location

City Oncology Hospital # 62

Moscow Region, Moscow, 143423, Russia

Location

State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

Arkhangelsk, Primorskiy (Maritime) Kray, 163045, Russia

Location

Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

Kazan', Tatarstan Republic, Russia

Location

State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"

Chelaybinsk, 454087, Russia

Location

Cancer Research Center n.a. N.N. Blokhin

Moscow, Russia

Location

GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary

Nizhny Novgorod, 603081, Russia

Location

State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"

Saint Petersburg, 194044, Russia

Location

Saint-Petersburg State Medical University n. a. I. P. Pavlov

Saint Petersburg, Russia

Location

State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"

Yaroslavl, 150040, Russia

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Wythenshawe Hospital

Manchester, England, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; isophosphamide mustard; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 15, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

FR (8); US (40); CA (3); HU (2); IL (5); IT (3); PL (4); GB (1); AU (1); RU (11); TW (1)