Study Using CP-461 to Treat Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036075
• Other study ID #: OSI-461-006
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2002
• Last updated: October 14, 2011
• Start date: August 2001
• Est. completion date: December 2005

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• CP-461

Locations

Country	Name	City	State
United States	Columbia Presbyterian Medical Center	New York	New York
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Cell Pathways, OSI Pharmaceuticals

Country where clinical trial is conducted

United States,