RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment

Inclusion Criteria:

• Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
• Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination)
• Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
• Age 18 to 75 years old
• Estimated life expectancy of more than 3 months
• ECOG performance status of 2 or lower
• Adequate bone marrow function
• Adequate kidney function
• Adequate liver function
• No prior radiation therapy to more than 25 percent of BM
• Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
• Women of childbearing potential must have a negative pregnancy test on admission
• The patient must be able to understand the study and has given written informed consent to participate in the study

Exclusion Criteria:

• Other tumor types than adenocarcinoma
• Central nervous system metastases or prior radiation for CNS metastasis
• Gastric outlet obstruction or intestinal obstruction
• Evidence of active gastrointestinal bleeding
• Bony metastasis as the sole evaluable disease
• Past or concurrent history of neoplasm other than stomach cancer
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Thyroid disease