Study Using CP-461 to Treat Advanced Prostate Cancer

Astellas

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: CP-461

Study type

Interventional

Funder types

Industry

Identifiers

NCT00036075

OSI-461-006

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.