A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors
Inclusion Criteria:
- Must be 18 years or older
- Must have a performance status of at least 70% (able to carry on most normal
activities)
- Must have life expectancy of at least 3 months
- Must have adequate organ and marrow function as determined by lab tests
- Women of child-bearing potential and men must agree to use two forms of contraception
- Ability and willingness to sign a written informed consent document
- Histologically confirmed solid tumor malignancy that is metastatic or unresectable
Exclusion Criteria:
- Pregnant or breastfeeding and/or lactating women
- Patients who have received any other investigational agents within 28 days of the
first day of study drug
- Patients with known CNS metastases
- History of other carcinomas within last 5 years (except non-melanoma skin cancer,
in-situ cervical cancer, localized prostate cancer)
- Inadequately controlled hypertension
- Significant vascular disease
- Invasion or encasement of a major artery
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to day 1 of study drug
- Serious illness or medical condition
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting
- History of stroke
- HIV, Hepatitis C, Hepatitis B or other serious chronic infection
- Impairment of Gastrointestinal function or disease
- History of interstitial lung disease
- Patients who have had radiation therapy, hormonal therapy, biologic therapy or
chemotherapy for cancer within 28 days of receiving study drug.