Clinical Trial: Study of CEP-701 in Treatment of Prostate Cancer


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Study of CEP-701 in Treatment of Prostate Cancer

This study is currently recruiting patients.

Sponsored by:	Cephalon
Information provided by:	Cephalon

Purpose

The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

Condition	Treatment or Intervention	Phase
Prostate Cancer	Drug: CEP-701	Phase II

MedlinePlus related topics: Prostate Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate specific Antigen

Further Study Details:

Expected Total Enrollment: 30

Study start: October 2003; Study completion: October 2004

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

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male

Criteria

Inclusion Criteria:

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has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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 Criteria:

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

Location and Contact Information

Johns Hopkins Patient Referral Office 410-955-8964

Maryland
Johns Hopkins, Baltimore, Maryland, 21287, United States; Recruiting

Patient Referral Office 410-955-8964
Samuel Dunmeade, MD, Principal Investigator

More Information

Study ID Numbers: C0701a/203/ON/US
Record last reviewed: April 2004
Record first received: April 15, 2004
ClinicalTrials.gov Identifier: NCT00081601
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10

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