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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovoCure Ltd.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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