An Open Label Pilot Study of the NovoTTF-100L(O) System (NovoTTF Therapy) (200 kHz) Concomitant With Weekly Paclitaxel for Recurrent Ovarian Carcinoma
试验速览
- 阶段
- 1 期
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Number of patients prematurely discontinuing TTFields due to Skin Toxicity
研究概览
简要总结
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.
详细描述
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 vitro and in vivo ovarian carcinoma pre-clinical models both as a single modality treatment and in combination with paclitaxel. TTFields has also shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In a small scale pilot study, patients with stage IIIB- IV non-small cell lung cancer (NSCLC) who had had tumor progression after at least one line of prior chemotherapy received Pemetrexed together with NovoTTF Therapy applied to the chest and upper abdomen until disease progression. Efficacy endpoints were remarkably high compared to historical data for Pemetrexed alone.
In a large prospective, randomized trial, in recurrent glioblastoma (GBM). The outcome of subjects treated with NovoTTF Therapy was compared to those treated with an effective best standard of care chemotherapy (including bevacizumab). NovoTTF Therapy subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today. Similar results showing comparability of NovoTTF Therapy to best standard of care (BSC) chemotherapy were seen in all secondary endpoints. Recurrent GBM patients treated with the NovoTTF Therapy in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes. Finally, quality of life measures were better in NovoTTF Therapy subjects as a group when compared to subjects receiving effective best standard of care chemotherapy.
DESCRIPTION OF THE TRIAL:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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
研究组 & 干预措施
TTFields in combination with weekly paclitaxel
Patients will be treated continuously with the NovoTTF-100L(O) device, in addition to weekly paclitaxel.
干预措施: NovoTTF-100L(O) (Device)
TTFields in combination with weekly paclitaxel
Patients will be treated continuously with the NovoTTF-100L(O) device, in addition to weekly paclitaxel.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of patients prematurely discontinuing TTFields due to Skin Toxicity
时间窗: 1.5 yeras
Adverse Events Severity and Frequency
时间窗: 1.5 years
次要结局
- Overall Survival(1.5 years)
- CA-125 Response Rate and Duration of Response(1.5 years)
- Progression Free Survival(1.5 years)
- Overall Radiological Response Rate and Duration of Response(1.5 years)
- Patients' compliance with TTFields Therapy(1.5 years)
- 1 Year Survival Rate(1.5 years)