A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer

Pts must have histo or cyto conf pap histology metastatic renal cell carcinoma. Pts w/unresectable primary tumor, are eligible. Pts must have available and be willing to submit slides for central path review w/in 28 days of reg and tumor tissue (see Sect 15). Pts must have mx disease. At least 28 days must have elapsed from resection and pt recovered from any adverse effects. Pts with hx of brain mets are not eligible. Pts must not have rec'd any prior chemo or immunotherapy. Pts may have rec'd prior RT, but must have mx disease outside RT port and at least 21 days must have elapsed and pt recovered from all associated toxicities. Pts must have a Zubrod PS of 0-2. Pts must have WBC >/= 3,000; ANC >/= 1,500; PLT >/=100,000; bili </= 1.5 x IULN; SGOT or SGPT </= 1.5 x IULN unless liver is involved in which SGOT or SGPT must be </= 5 x IULN; creat </= 2 x IULN. These tests must be obtained w/in 14 days prior to reg. Pts with a known hx of corneal diseases (see Section 5.13) are not eligible. Pts known to be HIV-positive and receiving combination anti-retroviral therapy are not eligible. Pts must not have GI tract disease resulting in an inability to take oral meds (see Section 5.15). Pts must not be pregnant or nursing. No other prior malignancy is allowed.