Study Using CP-461 to Treat Advanced Prostate Cancer

NCT00036075 | Completed Phase 2

• 1 other identifier: OSI-461-006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate

Interventions

CP-461 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Cell Pathways: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (2)

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

University of Washington

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

(5-fluoro-2-methyl-1-(4-pyridyl)methylene-3-(N-benzyl)-indene)-acetamide hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2002
• First Posted: May 8, 2002
• Study Start: August 1, 2001
• Study Completion: December 1, 2005
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

US (2)