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Study Using CP-461 to Treat Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00036075
Recruitment Status : Completed
First Posted : May 8, 2002
Last Update Posted : October 17, 2011
Sponsor:
Collaborators:
Cell Pathways
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: CP-461 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2001
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036075


Locations
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, Washington
University of Washington
Seattle, Washington, United States
Sponsors and Collaborators
Astellas Pharma Inc
Cell Pathways
OSI Pharmaceuticals

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00036075     History of Changes
Other Study ID Numbers: OSI-461-006
First Posted: May 8, 2002    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Astellas Pharma Inc:
prostate cancer
prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases