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

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ClinicalTrials.gov Identifier: NCT00585416
Recruitment Status : Terminated (Further evaluation of phase I dosing)
First Posted : January 3, 2008
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
Progen Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: CGC-11047 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
Study Start Date : June 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Drug: CGC-11047
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Throughout and for 28 days post drug ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585416


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Progen Pharmaceuticals

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585416     History of Changes
Other Study ID Numbers: HSC2006-0099
CO06801
47-02-001
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: April 2009

Keywords provided by University of Wisconsin, Madison:
Prostate Cancer
Hormone Refractory
Metastatic

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs