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Study of CEP-701 in Treatment of Prostate Cancer



Study of CEP-701 in Treatment of Prostate Cancer

For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Cephalon ,
Synopsis: The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.
Details: 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:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry 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CT scans - has increasing serum PSA concentrations - life expectancy of at least 3 months - ECOG of 0 or 1 - has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period Exclusion Criteria: - has asymptomatic disease - has active GI ulceration or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
Total Enrollment: 30

Location and Contact Information:

Johns Hopkins *Recruiting*
Baltimore,  Maryland,  21287
United States
Recruiting Patient  Office 410-955-8964


Additional Information:
Study ID Numbers:  C0701a/203/ON/US; 
Study Start Date: October 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081601

Other Prostate Cancer Studies:
1. Facilitating Shared Decisionmaking About Prostate Cancer Screening

2. PSA-Based Vaccine and Radiotherapy to Treat Localized Prostate Cancer

3. To explore racial differences in potential risk factors for developing prostate cancer in the VA population.

4. ProvengeĀ® Immunotherapy Vaccine for the Treatment of Metastatic Prostate Cancer after Failing Hormone Therapy

5. A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy

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