Status:
UNKNOWN
Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE)
Lead Sponsor:
NovoCure Ltd.
Conditions:
Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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) co...
Detailed Description
PAST PRE CLINICAL AND CLINICAL EXPERIENCE: The effect of the electric fields generated by the NovoTTF-100L(O) device (Tumor Treating Fields, TTFields, TTF) has demonstrated significant activity in in...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
- Recurrent ovarian cancer with any number of prior therapies
- 18 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
- No concurrent anti-tumor therapy (beyond weekly paclitaxel and NovoTTF Therapy as per protocol)
- At least 4 weeks since major surgery
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02244502
Start Date
September 1 2014
End Date
December 1 2016
Last Update
September 21 2016
Active Locations (5)
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1
Leuven, Belgium
2
Charité - Universitätsmedizin Berlin
Berlin, Germany
3
Hospitale Universitario 12 de Octubre
Madrid, Spain
4
Ospedale San Giovanni
Bellinzona, Switzerland