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
IntraDose-CDDP is a site-specific injectable therapy designed
to provide localized, sustained release of high concentrations
of cisplatin directly within the tumor, with decreased systemic
"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.