Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2001-08-31
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CP-461
Eligibility Criteria
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Inclusion 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.
18 Years
MALE
No
Sponsors
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Cell Pathways
INDUSTRY
OSI Pharmaceuticals
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Locations
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Columbia Presbyterian Medical Center
New York, New York, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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OSI-461-006
Identifier Type: -
Identifier Source: org_study_id