 - Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors RECIST; baseline measurements and evaluations of all sites of disease must be obtained 4 weeks prior to randomization; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy; persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiation therapy; radiographic findings are acceptable providing that clear-cut measurements can be made 