Status:
COMPLETED
Study of CEP-701 in Treatment of Prostate Cancer
Lead Sponsor:
Cephalon
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.
Detailed Description
A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.
Eligibility Criteria
Inclusion
- at least 18 yrs of age
- diagnosis of adenocarcinoma of the prostate
- no detectable metastatic disease as assessed by bone and CT scans
- has increasing serum PSA concentrations
- life expectancy of at least 3 months
- ECOG of 0 or 1
- has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
Exclusion
- has asymptomatic disease
- has active GI ulceration or bleeding
- has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
- bilirubin \>2x ULN or ALT or AST \>2xULN or serum creatinine \>1.5mg/dL
- hemoglobin \<9g/dL or platelets below 100,000/uL or ANC below 1500/uL
- receiving treatment for HIV with protease inhibitors
- has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
- has used investigational drug with previous one month
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00081601
Start Date
March 1 2004
End Date
June 1 2005
Last Update
August 24 2012
Active Locations (1)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21287