Primary Outcome Measures:
- To describe in an exploratory fashion the preliminary clinical efficacy (RR (CR+PR), PFS) of patients with refractory metastatic colorectal cancer treated with bevacizumab and RAD001. [ Time Frame: 2 years after start date ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To further describe toxicities associated with this regimen. [ Time Frame: every 28 days or as clinically indicated ] [ Designated as safety issue: Yes ]
- To describe the impact of this combination therapy on dermal wound and tumor angiogenesis and inhibition of factors including, but not limited to, VEGFR1, mTOR/p70S6K and other downstream and related markers in granulation tissue and tumor biopsies. [ Time Frame: 2 years after study start date ] [ Designated as safety issue: No ]
- To collect blood and urine-based biomarkers to evaluate for association with clinical efficacy for these patients and association with clinical outcome in these patients. [ Time Frame: Cycles 1 and 2 ] [ Designated as safety issue: No ]
This open-label, non-randomized expanded cohort trial of bevacizumab and RAD001 for patients with refractory metastatic colorectal cancer is designed to assess preliminary efficacy as well as the safety and tolerability of this combination. Patients will be accrued to this study at Duke University Medical Center, The Duke Oncology Outreach Network (DON), Wake Forest Baptist Medical Center and the University of North Carolina Medical Center
After satisfying eligibility and screening criteria, patients will be treated on 28 day cycles.
• The treatment regimen is as follows: Bevacizumab 10 mg/kg IV days 1, 15 RAD001 10 mg PO QD days 1-28
- Toxicity will be assessed every visit, and as clinically indicated.
- Efficacy will be assessed every 2 cycles, and as clinically indicated.
- Patients may remain on treatment as long as they are deemed to be clinically benefiting from treatment, do not have progressive disease on restaging imaging (Section 6.0), or do not have any other reason for discontinuation of treatment as outlined in Section 3.4.
- Patients will undergo correlative studies as outlined in the study protocol