A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate
Refractory to hormonal therapy Failed at least 1 nonhormonal therapy (prior radiotherapy
allowed, but does not constitute nonhormonal therapy) No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 60-100% Life expectancy: Not
specified Hematopoietic: No known or suspected red blood cell disorder (e.g., hereditary
spherocytosis, paroxysmal nocturnal hematuria, sickle cell trait, autoimmune hemolytic
disorder) Hepatic: Bilirubin no greater than 1.5 mg/dL No severe liver dysfunction,
particularly, no impaired hepatic synthetic functions as evidenced by prolonged
prothrombin time or otherwise unexplained serum albumin less than 3 g/dL Renal: Creatinine
no greater than 1.5 mg/dL Cardiovascular: No evidence of congestive heart failure No
clinically significant cardiac arrhythmia No prior or concurrent symptoms of acute
coronary artery disease No significant cardiac valve disease (e.g., aortic stenosis, valve
prosthesis) Pulmonary: No prior asthma during adulthood that required therapy Other: No
prior seizures or drug related anaphylactic reactions No history of microangiopathy (e.g.,
cavenous hemangioma, prior thrombotic thrombocytopenic purpura)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior systemic biologic
therapy for prostate cancer and recovered Chemotherapy: At least 4 weeks since prior
chemotherapy (12 weeks for strontium-89 and 6 weeks for bicalutamide) and recovered
Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics
No concurrent radiotherapy Surgery: At least 3 weeks since prior major thoracic or
abdominal surgery Other: At least 4 weeks since other prior investigational drugs (except
bisphosphonates) and recovered