Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer

A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)

The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.

Inclusion Criteria:

• Metastatic hormone refractory prostate cancer.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
• testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
• Progressive disease after androgen deprivation.

Exclusion Criteria:

• Patients whose clinical condition would make chemotherapy clearly indicated.
• Patients who have received systemic chemotherapy for the treatment of metastatic disease.
• Peripheral neuropathy > Grade 1
• Prior anti-angiogenic therapy, including thalidomide.
• Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
• Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
• Patients with known brain metastases or history of brain metastases.
• History of stroke within 6 months of treatment or other significant neurological limitations.
• Patients who have received more than 2 prior investigational treatments.
• Uncontrolled intercurrent illness
• Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias