Study Using CP-461 to Treat Advanced Prostate Cancer

The purpose of this study is to investigate whether an investigational drug, CP-461, is safe and effective for the treatment of patients with prostate cancer and who have measurable disease.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: CP-461

• Study Type: Interventional
• Enrollment: 25
• Phase: Phase 2

Contacts and Locations

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

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

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

• Sponsor: Astellas Pharma Inc
• Collaborators: OSI Pharmaceuticals; Cell Pathways

Study record dates

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: May 7, 2002
• First Posted (Estimate): May 8, 2002

Study Record Updates

• Last Update Posted (Estimate): October 17, 2011
• Last Update Submitted That Met QC Criteria: October 14, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: prostate cancer; prostate
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: OSI-461-006