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)

NCT01971281 | Unknown Phase 1

• 1 other identifier: EF-20
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic adenocarcinoma; Pancreas tumor; Treatment; Minimal toxicity; TTFields; Tumor Treating Fields; Novocure

Outcome Measures

Primary Outcomes (2)

• Adverse Events Severity and Frequency

  1.5 years

• Feasibility based on compliance with TTFields therapy

  1.5 yeras

Secondary Outcomes (5)

• Progression Free Survival

  1.5 years

• Overall Survival

  1.5 years

• 1 Year Survival Rate

  1.5 years

• 6 Month Progression-Free Survival Rate

  1.5 years

• Overall Response Rate based on RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.

  1.5 years

Study Arms (2)

TTFilelds + gemcitabine

EXPERIMENTAL

Patients will be treated continuously with the NovoTTF-100L device, in addition to Gemcitabine.

Device: NovoTTF-100L; Drug: Gemcitabine

TTFields + gemcitabine+ nab-paclitaxel

EXPERIMENTAL

Patients will be treated continuously with the NovoTTF-100L device, in addition to Gemcitabine plus nab-paclitaxel

Device: NovoTTF-100L; Drug: Gemcitabine; Drug: nab-Paclitaxel

Interventions

NovoTTF-100L DEVICE

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.

Also known as: TTFields

TTFields + gemcitabine+ nab-paclitaxel; TTFilelds + gemcitabine

Gemcitabine DRUG

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.

Also known as: Gemzar

TTFields + gemcitabine+ nab-paclitaxel; TTFilelds + gemcitabine

nab-Paclitaxel DRUG

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.

Also known as: Abraxane

TTFields + gemcitabine+ nab-paclitaxel

Eligibility Criteria

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

You may qualify if:

• Diagnosis of unresectable locally advanced or metastatic adenocarcinoma of the pancreas with histologically or cytologically confirmed disease.
• years of age and older
• Life expectancy of at least 12 weeks
• Measureable or assessable disease according to the revised RECIST criteria version 1.1.
• ECOG (Eastern Cooperative Oncology Group) score 0-1
• Adequate bone marrow, liver and kidney function:
• Absolute neutrophil count ≥ 1.5 x 10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Hemoglobin ≥ 10 g/dL
• AST and/or ALT ≤ 3 x upper limit of normal range (ULN) or ≤ 5 x ULN if patient has documented liver metastases
• Bilirubin ≤1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN
• Coagulation status: PT and PTT within normal limits or within therapeutic limits for patients receiving anticoagulation.
• Able to operate the NovoTTF-100L System independently or with the help of a caregiver.
• No concurrent anti-tumor therapy (beyond gemcitabine or gemcitabine and nab-paclitaxel and TTField therapy as per protocol).

You may not qualify if:

• Known brain metastases or meningeal carcinomatosis.
• Any other malignancy requiring anti-tumor treatment in the past three years.
• Significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:
• 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).
• 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.
• Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
• 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.
• Implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.
• Known allergies to medical adhesives or hydrogel or nab-paclitaxel.
• Pregnant or breast feeding.
• Admitted to an institution by administrative or court order

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (6)

Hospital General Universitario de Elche

Elche, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Ramon Y Cajal

Madrid, Spain

Location

Hospital Universitario Carlos Haya

Málaga, Spain

Location

Hospital Universitario Santander

Santander, Spain

Location

HFR-Hopital Cantonal

Fribourg, Switzerland

Location

Related Publications (7)

• Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

  PMID: 15126372 BACKGROUND

• Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

  PMID: 17551011 BACKGROUND

• Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

  PMID: 19387848 BACKGROUND

• Pless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9.

  PMID: 21548832 BACKGROUND

• Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

  PMID: 22608262 BACKGROUND

• Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

  PMID: 23891283 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

ES (5); CH (1)