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

Prostate Cancer Clinical Trial

Official title:

A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00585416
• Other study ID #: HSC2006-0099
• Secondary ID: CO0680147-02-001
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: September 30, 2015
• Start date: June 2006
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: March 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Progen Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		8 weeks	No
Secondary	Safety		Throughout and for 28 days post drug	Yes