Trial record 2 of 19 for:    novocure

Safety and Efficacy of TTFields Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by NovoCure Ltd.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT02397928
First received: March 19, 2015
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
The study is a prospective, single arm, non-randomized, open label phase II trial, designed to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Condition Intervention Phase
Malignant Pleural Mesothelioma
Device: NovoTTF-100L device
Drug: Pemetrexed
Drug: Cisplatin or Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed and Cisplatin or Carboplatin in Combination With NovoTTF Therapy as First-line Treatment in Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TTFields concomitant to pemetrexed plus cisplatin/carboplatin
Patients will be treated continuously with TTFields, in addition to pemetrexed plus cisplatin/carboplatin
Device: NovoTTF-100L device
Patients will be treated continuously with the NovoTTF-100L device. NovoTTF-100L treatment will consist of wearing four electrically insulated electrode arrays on the thorax. The treatment enables the patient to maintain regular daily routine.
Other Name: TTFields
Drug: Pemetrexed
Pemetrexed 500 mg/m2 will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on day 1 of a 21-day cycle.
Drug: Cisplatin or Carboplatin
Cisplatin 75 mg/m2 or carboplatin AUC 5 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end on the pemetrexed infusion on day 1 of a 21-day cycle.

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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathological or histological evidence of mesothelioma
  2. ≥ 18 years of age
  3. Not candidate for curative treatment (surgery or radiotherapy)
  4. At least 4 weeks since major surgery
  5. At least one measurable or evaluable lesion according to modified RECIST Criteria
  6. ECOG Performance Status of 0-1
  7. Life expectancy of at least 3 months
  8. Participants of childbearing age must use effective contraception as indicated by the investigator
  9. All subjects must sign written informed consent.
  10. Able to operate the NovoTTF-100L System independently or with the help of a caregiver

Exclusion Criteria:

  1. Patient candidate for surgery or radiotherapy with curative intent
  2. Previous chemotherapy or radiation
  3. Prior malignancy requiring anti-tumor treatment (apart from in-situ cervical cancer, in situ breast cancer, non-melanomatous skin cancers, or any malignancy for which treatment was received and there is no evidence of disease for at least 5 years) or concurrent malignancy
  4. Significant co-morbidities within 4 weeks prior to enrollment, resulting in the following laboratory findings:

    1. Significant liver function impairment:

      • AST or ALT > 3 times the upper limit of normal
      • Total bilirubin ≥ 1.5 times upper limit of normal
    2. Significant renal impairment (serum creatinine > 1.7 mg/dL)
    3. Coagulopathy (as evidenced by PT or APTT >1.5 times control in subjects not undergoing anticoagulation)
    4. Thrombocytopenia (platelet count < 100 x 10^3/μL)
    5. Neutropenia (absolute neutrophil count < 1.5 x 10^3/μL)
    6. Anemia (Hb < 10 g/dL)
    7. Severe acute infection
  5. Significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:

    1. History of significant cardiovascular disease unless the disease is well controlled.

      Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)

    2. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
    3. Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy
    4. History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent
  6. Untreated brain metastases. Asymptomatic, pretreated brain metastases not requiring steroids are allowed
  7. Implanted pacemaker, defibrillator or other electrical medical devices
  8. Known allergies to medical adhesives or hydrogel
  9. Pregnant or breast feeding (all patients of childbearing potential must use effective contraception method during the entire period of the study based on the recommendation of the investigator or a gynecologist)
  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: NCT02397928

Contacts
Contact: Uri Weinberg, MD PhD patientinfo@novocure.com

Locations
Belgium
Antwerp University Hospital, Thoracic Oncology Recruiting
Antwerp, Belgium
Contact: Brigitta Hiddinga, MD    + 32 3821 4121    Birgitta.hiddinga@uza.be   
Contact: Iris Verhaegen    +32 3821 5681    Iris.Verhaegen@uza.be   
Principal Investigator: Brigitta Hiddinga, MD         
Italy
A.S.O. "SS Antonio e Biagio e Cesare Arrigo" Recruiting
Alessandria, Italy
Contact: Federica Grosso, MD       federica.grosso@ospedale.al.it   
Contact: Annalisa Roveta, Dr.    +39-0131-206976      
Principal Investigator: Federica Grosso, MD         
Cliniche Humanitas Gavazzeni Recruiting
Bergamo, Italy
Contact: Giovanni Luca Ceresoli, MD    +39 035 420 4663    giovanni_luca.ceresoli@gavazzeni.it   
Contact: Paola Maggioni, Dr    +39 035 420 4760    paola.maggioni@gavazzeni.it   
Principal Investigator: Giovanni Luca Ceresoli, MD         
Ospedaliera di Perugia Recruiting
Perugia, Italy
Contact: Lucio Crinò, MD    +39 075 578 4211-4212      
Principal Investigator: Lucio Crinò, MD         
Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy
Contact: Caterina Orlando, Dr.    +39050996653    caterinaorlando79@gmail.com   
Contact: Simona Valleggi, Dr.       simona10.74@gmail.com   
Principal Investigator: Antonio Chella, MD         
Poland
Medical University Gdansk Recruiting
Gdansk, Poland
Contact: Rafal Dziadziuszko, Prof.    +48 58 349 2979    rafald@gumed.edu.pl   
Contact: Jaroslaw Madrzak, MD    +48 604 878 456    jmadrzak@gumed.edu.pl   
Principal Investigator: Rafal Dziadziuszko, Prof.         
Sub-Investigator: Jaroslaw Madrzak, MD         
Katedra i Klinika Onkologii Uniwersytetu Medycznegi im. Karola Marcinkowskiego w Poznaniu Recruiting
Poznań, Poland
Contact: Rodryg Ramlau, Prof.    +48 61 854 9040    rodryg.ramlau@skpp.edu.pl   
Contact: Lukasz Spychalski, Dr.    +48 61 854 9040    lspychalski@wp.pl   
Principal Investigator: Rodryg Ramlau, Prof.         
Spain
Vall d' Hebron Institute of Oncology (VHIO) Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Susanna Cedres, MD       scedres@vhebron.net   
Contact: Andrea Retter Valls    +34 93 489 43 75    aretter@vhio.net   
Principal Investigator: Susanna Cedres, MD         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Giovanni Luca Ceresoli, MD Cliniche Humanitas Gavazzeni
  More Information

Publications:

Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT02397928     History of Changes
Other Study ID Numbers: EF-23 
Study First Received: March 19, 2015
Last Updated: April 11, 2016
Health Authority: Italy: Ministry of Health

Keywords provided by NovoCure Ltd.:
Malignant Pleural Mesothelioma
Treatment
Minimal toxicity
TTFields
Tumor Treating Fields
Novocure
Pemetrexed
Carboplatin
Cisplatin

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2016