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Study Using CP-461 to Treat Advanced Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Cell Pathways
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036075
First received: May 7, 2002
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Drug: CP-461
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 25
Study Start Date: August 2001
Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00036075     History of Changes
Other Study ID Numbers: OSI-461-006
Study First Received: May 7, 2002
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013