Phase 1 Clinical Trial Is Assessing Cantrixil in Ovarian Cancer Patients Who Are Resistant to Chemo

Phase 1 Clinical Trial Is Assessing Cantrixil in Ovarian Cancer Patients Who Are Resistant to Chemo

Three Australian and two American cancer centers are spearheading the first clinical trial of Cantrixil, Novogen’s therapy to restore ovarian cancer patients’ sensitivity to chemotherapy.

Associate Professor Jim Coward, an oncologist at Icon Cancer Care in South Brisbane, is directing the trial. In addition to Icon, the Australian trial locations are the Flinders Medical Center and Westmead Hospital in Sydney. The trial partners in the United States are the Peggy and Charles Stephenson Cancer Center and the Mary Crowley Cancer Research Center.

A key objective of the Phase 1 trial (NCT02903771), which began enrolling participants in August 2016, is to see if Cantrixil is safe for patients with recurring ovarian cancer. Researchers are administering it once a week through the peritoneum, or abdominal cavity.

Novogen is still recruiting patients for the study. In addition to ovarian cancer patients, it is encouraging women with cancer of the fallopian tubes or peritoneum to enroll.

Besides seeing whether Cantrixil is safe, the trial will allow researchers to determine the drug’s maximum tolerated dose.

“The survival rate for ovarian cancer is poor because of the high rate of relapse after standard-of-care treatment and the late stage at which the disease tends to be diagnosed,” Coward said in a press release. “The vast majority of patients who relapse will eventually become resistant to chemotherapy, so it’s imperative that we have a bigger portfolio of treatment options.”

He added that “we’ve seen massive developments in other types of cancer, but ovarian cancer has remained a challenge and, despite it being an unforgiving disease for women, treatment options have fallen behind as money and research are focused elsewhere.”

Recurring ovarian cancer means that during an initial round of treatment, a small group of cells is able to resist the chemotherapy. These slow-growing cells have stem-cell-like properties and are capable of repopulating the tumor.

Cantrixil is a first-in-class drug that goes after the vast range of cells that populate a tumor, including  cancer stem cells.

The therapy “could be a compelling treatment for patients with recurrent ovarian cancer because it has shown evidence in the laboratory of being able to target and kill the sub-population of cancer stem cells or tumor-initiating cells that are responsible for cancers originating, metastasizing [spreading to other parts of the body] and relapsing,” Coward said.

“This new treatment is being developed as an IP [intraperitoneal] chemotherapy that we hope will be used as both first-line and recurrent therapies in combination with carboplatin administered intravenously (IV) for epithelial ovarian cancer, which is the most common form of ovarian cancer, comprising 90 percent of cases,” he said. “We know that if a surgeon is able to remove all of the visible disease during an ovarian cancer patient’s initial operation, combination IP and IV therapy is associated with vastly superior outcomes.”