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Study Using CP-461 to Treat Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CP-461
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia Presbyterian Medical Center
  • University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 7, 2002
Last Updated
October 14, 2011
Sponsor
Astellas Pharma Inc
Collaborators
Cell Pathways, OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00036075
Brief Title
Study Using CP-461 to Treat Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Cell Pathways, OSI Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CP-461

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study Using CP-461 to Treat Advanced Prostate Cancer

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