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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy

Outcome Time Frame:

8 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

HSC2006-0099

NCT ID:

NCT00585416

Start Date:

June 2006

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Hormone Refractory
  • Metastatic
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001