Phase II Trial To Evaluate Irofulven Dosing Schedule.(for epithelial ovarian cancer treatment)

2001 APR 12 - (NewsRx.com & NewsRx.net) -- MGI Pharma, Inc. (MOGN) March 22, 2001, announced that it has initiated a new Phase II clinical trial of irofulven, its anti-cancer compound, for patients with refractory or recurrent advanced epithelial ovarian cancer.

This multi-center Phase II trial will evaluate irofulven using a bi-weekly dosing schedule in up to 65 patients to develop recommendations for an anticipated Phase III trial with irofulven in advanced ovarian cancer.

This trial is being conducted based in part upon the anti-cancer activity seen in trials sponsored by MGI and the U.S. National Cancer Institute (NCI). Tumor shrinkage, including a complete response in the NCI Phase II ovarian cancer trial, and a complete response in an ovarian cancer patient using the bi-weekly dosing schedule in a dose optimization trial, have prompted further development of irofulven for the treatment of ovarian cancer. The intermittent, dosing schedule for irofulven is being used, based upon the greatly improved tolerance and demonstrated anti-cancer activity that was seen with this schedule in the dose optimization trial.

The patient enrollment period for this Phase II trial is expected to last approximately 12-18 months.

"We are excited to further explore the activity that has been demonstrated in earlier trials of irofulven for ovarian cancer patients," said Dr. David S. Alberts, professor of Medicine, Pharmacology and Public Health and associate dean for research, College of Medicine and Arizona Cancer Center, University of Arizona, and lead investigator for MGI's trial. "Because of the evidence and anti-tumor activity seen in ovarian cancer patients who have failed prior therapies, and because of the improved tolerance and diminished toxicity with the new dosing schedule, we are eager to determine irofulven's role in treating these patients."

The current first-line treatment of advanced ovarian cancer consists mainly of surgery followed by combination chemotherapy consisting of paclitaxel (Taxol[R]) and carboplatin (Paraplatin[R]), the two most commonly prescribed drugs.

"Most ovarian cancer patients will eventually develop platinum- and paclitaxel-resistance, and salvage chemotherapy in this group is much less effective than ...