MENLO PARK, Calif--Matrix Pharmaceutical, Inc. has begun phase III clinical testing of its IntraDose-CDDP injectable gel (see image) for treatment of recurrent head and neck cancer and other accessible tumors.
IntraDose-CDDP is a site-specific injectable therapy designed to provide localized, sustained release of high concentrations of cisplatin(Drug information on cisplatin) directly within the tumor, with decreased systemic toxicity.
"The start of this phase III program is a significant advance in Matrix's oncology program," Craig R. McMullen, president and CEO, told Oncology News International.
In a phase II trial presented last year at the American Society of Clinical Oncology (ASCO) meeting, 34 (48%) of 71 evaluable solid tumors exhibited a complete response to IntraDose-CDDP, and no significant adverse reactions were seen. The study included 31 patients with recurrent or refractory disease.
"We were particularly encouraged to note that an even greater number of complete responses was seen in tumors of patients with adenocarcinoma (81%) and squamous cell carcinoma (59%)," Mr. McMullen said.
The head and neck portion of the phase III program consists of two randomized, double-blind, placebo-controlled studies of patients with recurrent squamous cell carcinoma. One trial will be conducted in Europe, with clinical sites in Great Britain, Germany, and Holland, while an identical trial will take place at sites in the United States. Approximately 90 patients will be enrolled in each study.
Two separate open-label trials of patients with accessible solid tumors will be conducted in the United States and Europe with approximately 60 patients in each trial. Tumors that may be treated in this study include recurrent cases of breast cancer, malignant melanoma, lung cancer, sarcoma, and colorectal cancer.