A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Inclusion criteria

• Histologically or cytologically proven gastric cancer patients
• Adequate organ function as defined by the following criteria:

A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total serum bilirubin ≤ 3.0 mg/dL C. Absolute neutrophil count (ANC) ≥1500/µL D. Platelets ≥100,000/µL E. Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤12.0 mg/dL G. Serum creatinine ≤1.5 x ULN

• Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
• Patients who have failed to at least two previous cytotoxic chemotherapy for advanced gastric cancer (adjuvant treatment will be counted as one regimen if received < 12 months from the start of experimental treatment)
• At least one measurable lesion by RECIST criteria
• ECOG PS 0-2
• Patients with informed consent

Exclusion criteria

• Major surgery or radiation therapy within 4 weeks of starting the study treatment.
• History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
• Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
• Pregnancy or breastfeeding.
• Prior exposure to the study drug.
• Patients unable to swallow oral medications.