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

NCT ID: NCT00585416

Last Updated: 2015-10-02

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-03-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)

Group Type EXPERIMENTAL

CGC-11047

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Progen Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

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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