A Phase 3 clinical trial will investigate the impact of adding Tumor Treating Fields (TTFields), a method that uses electric fields to disrupt cell division, to Taxol (paclitaxel) for the treatment of ovarian cancer patients who are resistant to platinum-based chemotherapy.
Details of the clinical trial will be presented June 4 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 1-5 in Chicago, in a poster titled, “INNOVATE-3: Phase 3 randomized, international study of tumor treating fields (200 kHz) concomitant with weekly paclitaxel for the treatment of platinum-resistant ovarian cancer.”
The U.S. Food and Drug Administration approved Novocure‘s TTFields as a noninvasive, regional treatment method for newly diagnosed glioblastoma, an aggressive type of brain cancer.
TTFields disrupts cancer cell division by delivering intermediate frequency alternating electric fields and activating cells’ “suicide” programs.
For ovarian cancer patients, the therapy is delivered by four electrodes placed on a woman’s torso within the region surrounding the tumor. The delivery system is portable and allows patients to maintain a regular daily routine.
Previous results of preclinical models of ovarian cancer showed that TTFields, delivered at a frequency of 200 kHz, reduced the viability of cancer cells.
The Phase 2 INNOVATE trial (NCT02244502) showed that adding TTFields to Taxol is safe and extends the time a patient lives without disease worsening, from 3.9 months — historical controls treated with Taxol alone — to 8.9 months.
Now, the Phase 3 INNOVATE-3 study will determine if TTFields plus weekly Taxol is better than weekly Taxol alone at extending the survival of ovarian cancer patients with platinum-resistant disease.
Secondary objectives include the time a patient lives without disease progression, objective response rate, severity and frequency of adverse events, and patient-reported impact on quality of life.
Patients eligible to enroll must have had their last platinum therapy at least six months before enrollment with no more than two cycles after the diagnosis of platinum-resistant ovarian cancer. Those who received more than five prior lines of systemic therapy are not eligible to participate.
Participants will all receive Taxol weekly for eight weeks, followed by treatment at days 1, 8, and 15 of each subsequent 28-day cycle. Those assigned to TTFields will receive the treatment for at least 18 hours a day, on average. Patients may continue to use TTFields as long as there is no tumor worsening.
Clinical response will be assessed every four weeks, and imaging scans — computed tomography or magnetic resonance imaging — of the abdomen and chest will be conducted every eight weeks.