Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
NCT ID: NCT00585416
Last Updated: 2015-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2006-06-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
CGC-11047
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Interventions
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CGC-11047
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Progen Pharmaceuticals
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Locations
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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CO06801
Identifier Type: -
Identifier Source: secondary_id
47-02-001
Identifier Type: -
Identifier Source: secondary_id
HSC2006-0099
Identifier Type: -
Identifier Source: org_study_id
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