Study of CEP-701 in Treatment of Prostate Cancer - Full Text View

Purpose

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

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

MedlinePlus related topics:

Cancer Prostate Cancer

Drug Information available for:

CEP 701

U.S. FDA Resources

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 as provided by Cephalon:

Estimated Enrollment:	30
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081601

Locations


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

Sponsors and Collaborators

Cephalon

More Information

Study ID Numbers:	C0701a/203/ON/US
First Received:	April 15, 2004
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00081601
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

prostate cancer

prostate specific antigen

PSA

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00081601