Trial Success With Ovarian Cancer Med

Clinical trial found medication successful at reducing tumor growth in ovaries

(RxWiki News) When chemotherapy doesn’t work, the future can look pretty bleak. But new medications to combat gene mutations that cause cancer can offer hope to patients.

A phase II clinical trial for selumetinib to treat low-grade serous carcinoma in the ovaries and abdominal lining was successful enough to move onto a phase III trial.

The medication did have severe side effects for some patients, but no deaths occurred. 

"Talk to a doctor about your best cancer treatment options."

John Farley, MD, from the Division of Gynecologic Oncology at St. Joseph’s Hospital and Medical Center in Phoenix, AZ, led a clinical trial to test selumetinib for treatment of low-grade serous ovarian carcinoma. During the trial, 15 percent of patients had a reduction in tumor size and 65 percent had no further tumor growth. 

Selumetinib is a new medication that has not yet been made available outside clinical trials. Selumetinib was designed to target mutations in the MAPK protein, which occur in low-grade serous cancers of the ovaries and peritoneum (abdominal lining).

This small phase II clinical trial included 52 women with low-grade serous carcinoma-type cancer in the ovaries or peritoneum. Each patient had been through unsuccessful chemotherapy before the trial. Patients were given 50 mg of selumetinib twice per day throughout the trial.

Results of the trial showed that eight patients had an objective response to the treatment and 34 patients stabilized with no tumor growth. No patients died from bad reactions to the medication during the two-year trial.

Only three patients had potentially life-threatening toxic reactions to the medication. Severe, but not life-threatening, toxic reactions were reported by several patients. The reactions included: skin rashes, stomach upset, fatigue, pain, weakness, anemia (low red blood cell count) and heart trouble. 

“There just aren’t very good treatments for low-grade ovarian cancer, so this discovery opens up a lot of new exciting possibilities for us,” said Dr. Farley.

The phase III clinical trial for selumetinib has been scheduled to begin within the next few weeks. Upon successful completion of a phase III trial, the US Food and Drug Administration will review evidence and decide whether selumetinib should be put on the market for use.

Authors concluded this clinical trial has shown that a medication targeting mutations in MAPK protein pathways was successful in reducing this specific type of cancer growth. And further studies should continue to investigate MAPK protein mutations and ways to combat those mutations.

This study was published in February in The Lancet Oncology.

The National Cancer Institute provided funding for this project. No conflicts of interest were declared.

Review Date: 
February 16, 2013