Patient enrollment has begun for a phase II trial to evaluate efficacy and safety of glufosfamide for patients with recurrent, sensitive small cell lung cancer. The trial will be conducted in the USA, Russia, and the Ukraine.

"The fatality rate among patients with recurrent small cell lung cancer is unfortunately high," said John C. Ruckdeschel, MD, Karmanos Cancer Institute, and a clinical investigator for the trial. "Currently available second-line chemotherapy has very limited expectations of benefit. This clinical trial explores another treatment option for these patients."

The current standards of care in treating recurrent, sensitive small cell lung cancer are a variety of single agent and combination regimens including topotecan, cyclophosphamide, doxorubicin, vincristine, irinotecan, ifosfamide and cisplatin.

Approximately 50 patients with extensive recurrent sensitive small cell lung cancer, who have progressed at least 60 days after completing chemotherapy, are planned to enroll in the Phase II, open-label, clinical trial at various sites in the United States, Ukraine and Russia. All patients are to receive 5000 mg/m2 of glufosfamide every three weeks for up to six cycles.

The primary efficacy endpoint of the trial is objective response rate. The secondary endpoints of the trial will evaluate duration of response, progression-free survival, overall survival, time to response, and various safety and pharmacokinetic parameters. The study will also evaluate the effects of glufosfamide on lung cancer symptoms utilizing the Lung Cancer Symptom Scale (LCSS).

The clinical trial will utilize a two-stage design to ensure there is an adequate response rate to justify complete enrollment. The first stage will enroll 21 patients and, at the end of this stage, the trial will be stopped if fewer than 3 patients have a response. If 3 or more responses are observed, an additional 29 patients will be enrolled. Tumor response will be evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST).