Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE)

NCT02244502 | Unknown Phase 1

• 1 other identifier: EF-22
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 5

Brief Summary

The study is a prospective, single arm, non-randomized, open label pilot trial, designed to study the safety, toxicity, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L(O) concomitant with weekly paclitaxel in recurrent ovarian carcinoma 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.

Conditions

Ovarian Carcinoma

Keywords

Ovarian Carcinoma; Treatment; Minimal toxicity; TTFields; Tumor Treating Fields; Novocure; Paclitaxel; Weekly paclitaxel

Outcome Measures

Primary Outcomes (2)

• Adverse Events Severity and Frequency

  1.5 years

• Number of patients prematurely discontinuing TTFields due to Skin Toxicity

  1.5 yeras

Secondary Outcomes (6)

• Progression Free Survival

  1.5 years

• Overall Survival

  1.5 years

• 1 Year Survival Rate

  1.5 years

• Overall Radiological Response Rate and Duration of Response

  1.5 years

• CA-125 Response Rate and Duration of Response

  1.5 years

Study Arms (1)

TTFields in combination with weekly paclitaxel

EXPERIMENTAL

Patients will be treated continuously with the NovoTTF-100L(O) device, in addition to weekly paclitaxel.

Device: NovoTTF-100L(O); Drug: Paclitaxel

Interventions

NovoTTF-100L(O) DEVICE

Patients will be treated continuously with the NovoTTF-100L(O). NovoTTF-100L(O) treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.

TTFields in combination with weekly paclitaxel

Paclitaxel DRUG

Paclitaxel 80 mg/m2 over 1 hour infusion will be administered weekly for 8 weeks and then on days 1, 8, 15 of each subsequent 28 day cycle.

Also known as: Taxol

TTFields in combination with weekly paclitaxel

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
• Recurrent ovarian cancer with any number of prior therapies
• years of age and older
• Life expectancy of at least 12 weeks
• Measurable disease according to the revised RECIST criteria version 1.1. A lesion in a previously irradiated field is considered "non-measurable" and cannot be a "target lesion".
• ECOG score 0-1 (see Appendix A)
• Adequate bone marrow, liver and renal functions:
• 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(O) System independently or with the help of a caregiver

You may not qualify if:

• Meningeal carcinomatosis or known brain metastases which have not been treated, require steroid treatment, or are symptomatic.
• Any other malignancy requiring anti-tumor treatment in the past three years, except resected non-melanomatous skin cancer, breast carcinoma in situ, adequately treated stage I breast cancer or in situ cervical cancer.
• Chemotherapy within 4 weeks prior to treatment start.
• Radiotherapy within 4 weeks prior to treatment start.
• 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 stable 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 history of sensitivity to taxanes or drugs containing Cremophor
• Grade 2 or greater peripheral neuropathy
• Known allergies to medical adhesives or hydrogel
• Pregnant or breast feeding

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (5)

Unknown Facility

Leuven, Belgium

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Hospitale Universitario 12 de Octubre

Madrid, Spain

Location

Ospedale San Giovanni

Bellinzona, Switzerland

Location

Kantonsspital Graubünden

Chur, 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

Ovarian Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Cristina Sessa, MD

  Ospedale San Giovanni

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-07

Locations

DE (1); ES (1); BE (1); CH (2)