- At least one target lesion that is unidimensionally measurable as defined by Response
Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been
previously irradiated; a tumor that expresses at least one member of the erbB family
of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated
core laboratory)
- Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or
treatment with investigational agents (including CI 1033); hormonal therapy within 28
days prior to baseline disease assessment (to exclude the possibility of a
hormone-withdrawal response); prior definitive radiation therapy to the primary cancer
site; not yet recovered from the acute effects of surgery or palliative radiotherapy;
brain metastases.