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

This study has been terminated.
(Further evaluation of phase I dosing)
Sponsor:
Collaborator:
Progen Pharmaceuticals
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585416
First received: December 21, 2007
Last updated: April 13, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: CGC-11047
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Throughout and for 28 days post drug ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: June 2006
Study Completion Date: March 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: George Wilding, PI for this study at University of Wisconsin, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00585416     History of Changes
Other Study ID Numbers: HSC2006-0099, CO06801, 47-02-001
Study First Received: December 21, 2007
Last Updated: April 13, 2009
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014