A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
Inclusion Criteria:
- Histologically or cytologically documented unresectable or metastatic adenocarcinoma
of stomach or gastroesophageal junction
- No history of chemotherapy or radiation
- Age 18 to 70 years old
- Estimated life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (white blood cell counts >3,000/uL, absolute neutrophil
count>1,500/uL, Platelets>100,000/uL, Hgb>8 g/dL)
- Adequate kidney function (creatinine<1.5 mg/dL)
- Adequate liver function (bilirubin<1.5 mg/dL, aspartate aminotransferase (AST) or
alanine aminotransferase (ALT) level <3 times the upper normal limit (5 times for
patients with liver metastasis))
- Signed written informed consent
Exclusion Criteria:
- Past or concurrent history of neoplasm other than gastric adenocarcinoma except for
curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix
uteri
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start
- Presence of central nervous system metastasis
- Bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy (NCI CTC AE version 3.0 > Grade I)
- History of significant neurologic or psychiatric disorders
- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception
- Other serious illness or medical conditions
- Patients with known history of ischemic heart disease and/or with myocardial
infarction
- Known allergy to study drugs
- Administration of drugs showing interaction with RAD001