Tom,
Unless I'm misreading the descriptions of the trials, they are both for refractory cases, among others. The Ph II also involves radiation therapy, so if that's the one he meant, he might have said so. The Ph III is for folks that have had radiation therapy, and involves only cisplatin and C225. Further, it doesn't seem likely that IMCL could file for approval after a Ph II. Here are the two descriptions from ImClone's website.
"a phase II study in newly diagnosed, locally recurrent or metastatic disease patients who are treated with combination therapy of concomitant boost radiation therapy, standard monthly cisplatin, and 12 weekly infusions of C225. This study is planned to start enrollment in the Summer of 1999.
a randomized, double blind, phase III study of patients, either newly diagnosed with extensive incurable local regional disease and distant metastases, or locoregional recurrence/persistence, or distant metastases after initial treatment with surgery or radiation therapy. Patients will receive standard monthly cisplatin in combination with either placebo or C225. This cooperative group study is planned to begin enrollment in early 1999."
Note that both of these descriptions come from the Head and Neck Cancer link on the web site, even though the indication is not indicated within the descriptions themselves.
I'm assuming "recurrent" and "refractory" are roughly synonymous. So the main difference is not "refractory," but the timing of the radiation therapy.
Cheers, Tuck |
