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Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR)

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ClinicalTrials.gov Identifier: NCT02397928
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Device: NovoTTF-100L device Drug: Pemetrexed Drug: Cisplatin or Carboplatin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pemetrexed and Cisplatin or Carboplatin in Combination With TTFields (150 kHz) as First-line Treatment in Malignant Pleural Mesothelioma
Actual Study Start Date : February 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]
  2. Response Rate [ Time Frame: 1 year ]
  3. Toxicity- incidence of adverse events [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397928


Locations
Belgium
Antwerp University Hospital, Thoracic Oncology
Antwerp, Belgium
France
Goustave Roussy - Cancer Campus Grand Paris
Villejuif, France
Germany
Universitätsklinikum Halle (Saale)
Halle, Germany
Italy
A.S.O. "SS Antonio e Biagio e Cesare Arrigo"
Alessandria, Italy
Cliniche Humanitas Gavazzeni
Bergamo, Italy
Ospedale Villa Scassi
Genoa, Italy
Ospedaliera di Perugia
Perugia, Italy
Ospedaliero Universitaria Pisana
Pisa, Italy
Netherlands
Erasmus Mc
Rotterdam, Netherlands
Poland
Medical University Gdansk
Gdansk, Poland
Katedra i Klinika Onkologii Uniwersytetu Medycznegi im. Karola Marcinkowskiego w Poznaniu
Poznań, Poland
Klinika Nowotworów Pluca I Klatki Piersiowej
Warsaw, Poland
Spain
Vall d' Hebron Institute of Oncology (VHIO) Hospital Vall d'Hebron
Barcelona, Spain
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Giovanni Luca Ceresoli, MD Cliniche Humanitas Gavazzeni

Publications:

Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT02397928     History of Changes
Other Study ID Numbers: EF-23
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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

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