Back to resultsStudy of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CGC-11047
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Hormone Refractory, Metastatic
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Safety
Full Information
NCT ID
NCT00585416
First Posted
December 21, 2007
Last Updated
September 30, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
Progen Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00585416
Brief Title
Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
Official Title
A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
Further evaluation of phase I dosing
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Progen Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Hormone Refractory, Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Intervention Type
Drug
Intervention Name(s)
CGC-11047
Intervention Description
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Safety
Time Frame
Throughout and for 28 days post drug
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
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