CP-461 in Prostate Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Drug: CP-461

Study Type

Interventional

Enrollment

25

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States, 10032
    - Columbia Presbyterian Medical Center
- Washington
  - Seattle, Washington, United States
    - University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Eligibility Criteria:

Male 18 years of age.
Histologically confirmed adenocarcinoma of the prostate, stage D1 or D2.
Failure of androgen ablation (orchiectomy or LHRH, flutamide).
Patients must have PSA progression and progression in measurable disease.
No prior history of systemic chemotherapy.
No investigational drugs within 4 weeks of study entry.
No radiation therapy or hormonal therapy within 4 weeks of study entry.
No isotope therapy within 6 weeks of study entry.
No antiandrogens within 4 weeks of study entry. Patients must continue LHRH.
If patients had prior surgery, it must be at least 21 days prior to study entry, and the patient must have recovered from all side effects.
Patients must have stopped bisphosphonates 28 days prior to study entry.
No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient is currently in remission, and has been disease free for at least 5 years.
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator not have significant active concurrent medical illness, such as a history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude protocol treatment or survival.
All patients must be informed of the investigational nature of the study and must sign and give written informed consent in accordance with institutional and federal guidelines.
No other chemotherapeutic, biological response modifiers, radiation therapy, corticosteroid therapy, or hormonal concomitant therapy (except continuation of LHRH) may be given during treatment. Patients should not be planning on receiving concomitant bisphosphonates.
ECOG Performance Status = 0-3.
WBC > or = 3500/ul or ANC > or = 1500/ul.
Bilirubin < or = ULN.
Creatinine < or = 2.0 mg/dl.
Platelets > or = 100,000/ul.
ALT or AST < 2.5 X ULN.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

OSI Pharmaceuticals

Cell Pathways

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

May 7, 2002

First Submitted That Met QC Criteria