A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer
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