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Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT01971281
First received: October 23, 2013
Last updated: September 20, 2016
Last verified: June 2016
  Purpose
The study is a prospective, double 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 or concomitant with gemcitabine plus nab-paclitaxel, 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
Drug: nab-Paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of TTFields (150 kHz) Concomitant With Gemcitabine and TTFields Concomitant With Gemcitabine Plus Nab-paclitaxel 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 TTFields 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 ]

Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TTFilelds + 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. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Other Name: TTFields
Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 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
Experimental: TTFields + gemcitabine+ nab-paclitaxel
Patients will be treated continuously with the NovoTTF-100L device, in addition to Gemcitabine plus nab-paclitaxel
Device: NovoTTF-100L
Patients will be treated continuously with the NovoTTF-100L. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Other Name: TTFields
Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 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
Drug: nab-Paclitaxel
nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on days 1, 8 and 15 of each 28-day cycle.
Other Name: Abraxane

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 or gemcitabine and nab-paclitaxel 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.
  12. Signed informed consent form

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 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.
  4. Implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.
  5. Known allergies to medical adhesives or hydrogel or nab-paclitaxel.
  6. Pregnant or breast feeding.
  7. Admitted to an institution by administrative or court order
  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

Locations
Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital 12 de Octubre
Madrid, Spain
Ramon Y Cajal
Madrid, Spain
Hospital Universitario Carlos Haya
Malaga, Spain
Hospital Universitario Santander
Santander, Spain
Switzerland
HFR-Hopital Cantonal
Freiburg, Switzerland
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Study Director: Rocio Garcia Carbonero, 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:
Moshe Giladi, Rosa S. Schneiderman, Yaara Porat, Mijal Munster, Aviran Itzhaki, Daniel Mordechovich, Shay Cahal, Uri Weinberg, Eilon D. Kirson, Yoram Palti. Tumor Treating Fields inhibit the growth of pancreatic and ovarian cancer in preclinical models . [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 5569. doi:10.1158/1538-7445.AM2013-5569

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: September 20, 2016
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
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016