Phase II Study of GW572016 (NSC #727989) as First Line Therapy in Patients with Advanced or Metastatic Gastric Cancer

Cytologically or pathologically verified gastric cancer. Locally advanced or distant metastatic disease (either recurrent or at primary diagnosis) that is not surgically curable. Measurable disease. Must be willing to have specimens submitted; specimens must be available. Must be at least 2 weeks beyond any surgery and recovered from all effects. May have received prior chemo, hormonal therapy, immunotherapy, radiation or chemoradiotherapy as neoadjuvant or adjuvant treatment but this must have been completed at least 6 months prior to documented recurrence or metastatic disease. Patients must not have received previous treatment for metastatic disease. If patient received radiation therapy, the site of measurable disease must be outside of the radiation field. Must not have had prior therapy with EGFR targeting therapies. Zubrod performance status of 0-1. Leucocytes greater than or equal to 3,000/mcl; platelets greater than or equal to 100,000/mcl; AGC greater than or equal to 1,500/mcl. SGOT/SGPT less than or equal to 2.5xIULN; bilirubin less than or equal to IULN. Patients with liver involvement must have SGOT/SGPT less than or equal to 5xIULN. Serum creatinine less than or equal to IULN OR measured creatinine clearance greater than 60 mL/min OR estimated creatinine clearance greater than 60 mL/min. Echocardiogram or MUGA scan within 42 days prior to registration; cardiac ejection fraction within institutional range of normal. Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube. No intractable nausea or vomiting, no GI tract disease resulting in inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn�s, ulcerative colitis). No history of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016. At least 18 years of age. No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer. No HIV-positive patients receiving combination anti-retroviral therapy. No pregnant or nursing women. Women/men of reproductive potential must have agreed to use an effective contraceptive method. No other prior malignancy except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in remission or any other cancer from which the patient has been disease-free for 5 years.