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

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Terminated
Phase 2

Conditions

Prostate Cancer

Treatments

Drug: CGC-11047

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00585416
CO06801
47-02-001
HSC2006-0099

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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