A phase II trial of TTFields in addition to pemetrexed and cisplatin or carboplatin as first-line treatment in malignant pleural mesothelioma
- Conditions
- Malignant pleural mesothelioma1002741210035597
- Registration Number
- NL-OMON43520
- Lead Sponsor
- ovocure Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 27
1. Pathological or histological evidence of mesothelioma.
2. * 18 years of age
3. Not candidate for curative treatment (surgery or radiotherapy)
4. At least 4 weeks since major surgery
5. At least one measurable or evaluable lesion according to modified RECIST Criteria
6. ECOG Performance Status (PS) of 0-1.
7. Life expectancy of at least 3 months.
8. Participants of childbearing age must use effective contraception as indicated by the investigator
9. All subjects must sign written informed consent.
10. Able to operate the NovoTTF-100L System independently or with the help of a caregiver.
1. Patient candidate for surgery or radiotherapy with curative intent
2. Previous chemotherapy or radiation
3. Prior malignancy requiring anti-tumor treatment (apart from in*situ cervical cancer, in situ breast cancer, non-melanomatous skin cancers, or any malignancy for which
treatment was received and there is no evidence of disease for at least 5 years) or
concurrent malignancy.
4. Significant co-morbidities within 4 weeks prior to enrollment, resulting in the following
laboratory findings:
a) Significant liver function impairment:
* AST or ALT > 3 times the upper limit of normal
* Total bilirubin > 1.5 upper limit of normal
b) Significant renal impairment (serum creatinine > 1.7 mg/dL)
c) Coagulopathy (as evidenced by PT or APTT >1.5 times control in subjects not receiving anticoagulants)
d) Thrombocytopenia (platelet count < 100 x 10e3/*L*
e) Neutropenia (absolute neutrophil count < 1.5 x 10e3/*L*
f) Anemia (Hb < 10 g/dL)
g) Severe acute infection
5. Significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:
a) 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).
b) 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
c) Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
d) 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. Untreated brain metastases. Asymptomatic, pretreated brain metastases not requiring steroids are allowed
7. Implanted pacemaker, defibrillator or other electrical medical devices
8. Known allergies to medical adhesives or hydrogel
9. Pregnant or breast feeding (all patients of childbearing potential must use effective contraception method during the entire period of the study based on the recommendation of the investigator or a gynecologist)
10. Admitted to an institution by administrative or court order
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint: Overall Survival (OS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>* Response Rate (RR)<br /><br>* Progression Free Survival (PFS)<br /><br>* Safety profile</p><br>