- (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous
chemotherapy for greater than 3 months prior to enrollment
- (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC)
previously untreated with any systemic therapy.
- Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last
treatment was > 12 months prior to enrollment,
- Patients must have measurable disease by RECIST and if any history of hypertension, it
must be controlled with medication.
- Prior system therapy for advanced CRC (Ph 2 portion only)
- Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
- Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
- Prior radiation, major surgery, or investigational agent within 4 weeks of study entry
except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries
should be completed > 2 weeks of enrollment and be fully recovered from any procedure.