Study Using CP-461 to Treat Advanced Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Columbia Presbyterian Medical Center, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CP-461

Drug

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

Cell Pathways
OSI Pharmaceuticals

Registry information

Important dates

Study start: 2001
Study completion: 2005
First posted: May 8, 2002
Registry last updated: Oct 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed