A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
- 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.
- Patients whose clinical condition would make chemotherapy clearly indicated.
- Patients who have received systemic chemotherapy for the treatment of metastatic
- 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
- 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
- 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