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

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ClinicalTrials.gov Identifier: NCT02244502
Recruitment Status : Unknown
Verified July 2016 by NovoCure Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

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.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Device: NovoTTF-100L(O) Drug: Paclitaxel Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study of the NovoTTF-100L(O) System (NovoTTF Therapy) (200 kHz) Concomitant With Weekly Paclitaxel for Recurrent Ovarian Carcinoma
Study Start Date : September 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: TTFields in combination with weekly paclitaxel
Patients will be treated continuously with the NovoTTF-100L(O) device, in addition to weekly paclitaxel.
Device: NovoTTF-100L(O)
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.

Drug: Paclitaxel
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.
Other Name: Taxol




Primary Outcome Measures :
  1. Adverse Events Severity and Frequency [ Time Frame: 1.5 years ]
  2. Number of patients prematurely discontinuing TTFields due to Skin Toxicity [ Time Frame: 1.5 yeras ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1.5 years ]
  2. Overall Survival [ Time Frame: 1.5 years ]
  3. 1 Year Survival Rate [ Time Frame: 1.5 years ]
  4. Overall Radiological Response Rate and Duration of Response [ Time Frame: 1.5 years ]
  5. CA-125 Response Rate and Duration of Response [ Time Frame: 1.5 years ]
  6. Patients' compliance with TTFields Therapy [ Time Frame: 1.5 years ]
    Patient compliance will be assessed by evaluating the device log file which will be downloaded every 4 weeks from the NovoTTF-100L(O) System. Compliance will be presented as an hourly average over a 24 hour period during the 4 weeks and as an average percentage of use over the 4 week period.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
  2. Recurrent ovarian cancer with any number of prior therapies
  3. 18 years of age and older
  4. Life expectancy of at least 12 weeks
  5. 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".
  6. ECOG score 0-1 (see Appendix A)
  7. Adequate bone marrow, liver and renal functions:

    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.
  8. Able to operate the NovoTTF-100L(O) System independently or with the help of a caregiver
  9. No concurrent anti-tumor therapy (beyond weekly paclitaxel and NovoTTF Therapy as per protocol)
  10. At least 4 weeks since major surgery

Exclusion Criteria:

  1. Meningeal carcinomatosis or known brain metastases which have not been treated, require steroid treatment, or are symptomatic.
  2. 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.
  3. Chemotherapy within 4 weeks prior to treatment start.
  4. Radiotherapy within 4 weeks prior to treatment start.
  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 stable 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. Implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.
  7. Known history of sensitivity to taxanes or drugs containing Cremophor
  8. Grade 2 or greater peripheral neuropathy
  9. Known allergies to medical adhesives or hydrogel
  10. Pregnant or breast feeding

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): NCT02244502


Locations
Belgium
Leuven, Belgium
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Spain
Hospitale Universitario 12 de Octubre
Madrid, Spain
Switzerland
Ospedale San Giovanni
Bellinzona, Switzerland
Kantonsspital Graubünden
Chur, Switzerland
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Cristina Sessa, MD Ospedale San Giovanni

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: NCT02244502     History of Changes
Other Study ID Numbers: EF-22
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: July 2016

Keywords provided by NovoCure Ltd.:
Ovarian Carcinoma
Treatment
Minimal toxicity
TTFields
Tumor Treating Fields
Novocure
Paclitaxel
Weekly paclitaxel

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action