Pharmacyclics Inc has opened two new Phase 1 trials of its investigative drug Xcytrin (motexafin gadolinium) Injection in combination with Taxotere (docetaxel) for the treatment of advanced solid tumors. These studies are based upon promising results of this combination therapy in animal models of cancer where the two drugs were shown to have a synergistic anticancer effect.

"Preclinical animal model studies have provided evidence that Xcytrin improves the anticancer effects of several commonly used chemotherapy drugs," said Nithya Ramnath, principal investigator, Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY. "These clinical studies are designed to evaluate the safety and benefit of Xcytrin in combination with docetaxel in treating patients with common solid tumors that have failed prior therapies; a situation where currently available treatments are inadequate."

The Phase 1 trials will each recruit approximately 25 patients with relapsed prostate, breast, lung or ovarian cancers that have failed initial chemotherapy. Each of the protocols is designed to evaluate Xcytrin in combination with different, but commonly used, docetaxel dosing regimens. One will evaluate Xcytrin in combination with docetaxel given every three weeks. This study will be conducted at the James P. Wilcot Cancer Center, University of Rochester Medical Center, Rochester, NY. The other protocol is designed to examine Xcytrin with docetaxel given weekly and will be conducted at the Roswell Park Cancer Institute, Dallas, TX.