A Study of Radiation With Sorafenib in Advanced Cancer

A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)

The purpose of this study is to test the combination of radiation treatment and an anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of this combination on cancers but also on side effects of radiation treatment. This study will also determine the highest safe dose of sorafenib that can be given with radiation treatment.

Inclusion Criteria:

• Advanced cancer not eligible for curative treatment.
• A measurable lesion in the thorax, abdomen or pelvis.
• Normal organ and bone marrow function.
• Able to receive protocol prescribed radiation. Please refer to the protocol for detailed inclusion criteria.

Exclusion Criteria:

• Overlap of treatment field with a previous radiation field.
• Inability to meet mandated normal tissue radiation dose constraints.
• Brain metastases (unless previously treated and controlled)
• Previous treatment with Sorafenib.
• Poorly controlled Hypertension.
• Unable to swallow sorafenib tablets.
• Intercurrent cardiac dysfunction.
• Uncontrolled intercurrent illness. Please refer to the protocol for detailed exclusion criteria.