EPO906 Therapy in Patients With Advanced Colorectal Cancer

Inclusion criteria

Patients must meet the following criteria to be eligible for the study:

• Histologically or cytologically documented evidence of colorectal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
• The patient should have failed or progressed on no more than two prior chemotherapies for metastatic disease (the prior chemotherapy must have included a fluoropyrimidine and either Irinotecan or oxaliplatin, or any combination of these agents, with the last chemotherapy having contained Irinotecan or oxaliplatin)
• Patients who have received only adjuvant therapy for their disease are eligible, as long as they have relapsed within six months of completing such therapy and that therapy contained 5-FU and Irinotecan or oxaliplatin administered in combination as part of an investigational protocol
• Must have a life expectancy of greater than three (3) months.

Exclusion criteria

The following patients are not eligible for the study:

• Patients with symptomatic CNS metastases or leptomeningeal involvement
• Patients with unresolved bowel obstruction
• Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
• Patients with severe cardiac insufficiency
• Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
• Patients with radiation therapy or chemotherapy within the last four weeks
• Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
• History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
• Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
• HIV+ patients
• Pregnant or lactating females