Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
- Registration Number
- NCT00585416
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 CGC-11047 CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
- Primary Outcome Measures
Name Time Method Efficacy 8 weeks
- Secondary Outcome Measures
Name Time Method Safety Throughout and for 28 days post drug
Trial Locations
- Locations (1)
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States