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Safety Feasibility and Effect of NovoTTF-100L Together With Gemcitabine for Front-line Therapy of Advanced Pancreatic Adenocarcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by NovoCure Ltd.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT01971281
First received: October 23, 2013
Last updated: February 4, 2014
Last verified: October 2013
  Purpose

The study is a prospective, single arm, non-randomized, open label pilot trial, designed to study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L concomitant with gemcitabine, for front-line therapy of pancreatic adenocarcinoma. 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
Pancreatic Adenocarcinoma
Device: NovoTTF-100L
Drug: Gemcitabine
Phase 1
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: An Open Label Pilot Study of NovoTTF-100L Concomitant With Gemcitabine for Front-line Therapy of Advanced Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Adverse Events Severity and Frequency [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • Feasibility based on compliance with NovoTTF Therapy. [ Time Frame: 1.5 yeras ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • 1 Year Survival Rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • 6 Month Progression-Free Survival Rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Overall Response Rate based on RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NovoTTF-100L device in combination with Gemcitabine
Patients will be treated continuously with the NovoTTF-100L device, in addition to Gemcitabine.
Device: NovoTTF-100L
Patients will be treated continuously with the NovoTTF-100L. NovoTTF-100L treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Drug: Gemcitabine
Gemcitabine 1000 mg/m2 over 30 minute infusion will be administered once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week rest from treatment. Subsequent cycles will consist of once weekly infusions days 1, 8, 15 every 28 days.
Other Name: Gemzar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of unresectable locally advanced or metastatic adenocarcinoma of the pancreas with histologically or cytologically confirmed disease.
  2. 18 years of age and older
  3. Life expectancy of at least 12 weeks
  4. Measureable or assessable disease according to the revised RECIST criteria version 1.1.
  5. ECOG (Eastern Cooperative Oncology Group) score 0-1
  6. Adequate bone marrow, liver and kidney function:

    1. Absolute neutrophil count ≥ 1.5 x 10 9/L
    2. Platelet count ≥ 100 x 10 9/L
    3. Hemoglobin ≥ 10 g/dL
    4. AST and/or ALT ≤ 3 x upper limit of normal range (ULN) or ≤ 5 x ULN if patient has documented liver metastases
    5. Bilirubin ≤1.5 x ULN
    6. Serum creatinine ≤ 1.5 x ULN
    7. Coagulation status: PT and PTT within normal limits or within therapeutic limits for patients receiving anticoagulation.
  7. Able to operate the NovoTTF-100L System independently or with the help of a caregiver.
  8. No concurrent anti-tumor therapy (beyond gemcitabine and TTField therapy as per protocol).
  9. No prior chemotherapy or radiation allowed.
  10. At least 4 weeks since major surgery.
  11. Prior surgery allowed for local disease provided a measurable lesion remains on the baseline CT scan.

Exclusion Criteria:

  1. Known brain metastases or meningeal carcinomatosis.
  2. Any other malignancy requiring anti-tumor treatment in the past three years.
  3. Significant comorbidity which is expected to affect patient's prognosis

    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.
  4. Implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.
  5. Known allergies to medical adhesives or hydrogel.
  6. Pregnant or breast feeding.
  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: NCT01971281

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

Locations
Germany
Berlin Charité Not yet recruiting
Berlin, Germany
Contact: Marianne Sinn Hanno Riess, MD    +49 (30) 450 553834    marianne.sinn@charite.de   
Principal Investigator: Marianne Sinn Hanno Riess, MD         
Universitätsklinikum Halle (Saale) Not yet recruiting
Halle, Germany
Contact: Jörn Rüssel Hans-Joachim Scholl, MD    +49 (345) 557 2924    joern.ruessel@uk-halle.de   
Principal Investigator: Jörn Rüssel Hans-Joachim Scholl, MD         
Spain
Hospital General Universitario de Elche Recruiting
Elche, Spain
Contact: Javier Gallego-Plazas, MD    +34 966 616250    j.gallegoplazas@gmail.com   
Principal Investigator: Javier Gallego-Plazas, MD         
Hospital 12 de Octubre Recruiting
Madrid, Spain
Contact: Jose Lopez-Martin, MD    +34 91 3908922    jalopezmartin@gmail.com   
Principal Investigator: Jose Lopez-Martin, MD         
Ramon Y Cajal Recruiting
Madrid, Spain
Contact: Carmen Guillen, MD    +34 91 3368263    carmenguillenponce@gmail.com   
Principal Investigator: Carmen Guillen, MD         
Hospital Universitario Carlos Haya Recruiting
Malaga, Spain
Contact: Manuel Benavides-Orgaz, MD    +34 951 291425    manuel.benavides.sspa@juntadeandalucia.es   
Principal Investigator: Manuel Benavides-Orgaz, MD         
Hospital Universitario Santander Recruiting
Santander, Spain
Contact: Fernando Rivera, MD    +34 942 202525    oncrhf@humv.es   
Principal Investigator: Fernando Rivera, MD         
Switzerland
HFR-Hopital Cantonal Not yet recruiting
Freiburg, Switzerland
Contact: Daniel Betticher, MD    +41 26 426 7111    Daniel.Betticher@h-fr.ch   
Principal Investigator: Daniel Betticher, MD         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Study Director: Jose Lopez-Martin, MD Hospital 12 de Octubre
Study Director: Carmen Guillen, MD Hospital Ramon Y Cajal
Study Director: Manuel Benavides-Orgaz, MD Hospital Universitario Carlos Haya
Study Director: Javier Gallego-Plazas, MD Hospital General Universitario de Elche
Study Director: Fernando Rivera, MD Hospital Universitario Santander
  More Information

Publications:

Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT01971281     History of Changes
Other Study ID Numbers: EF-20
Study First Received: October 23, 2013
Last Updated: February 4, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by NovoCure Ltd.:
Pancreatic adenocarcinoma
Pancreas tumor
Treatment
Minimal toxicity
TTFields
Tumor Treating Fields
Novocure

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014