Clinical trial NCT00244920 (phase 2, status: withdrawn)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: bicalutamide, leuprolide acetate, squalamine lactate
SMILES: [H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, CC(C)[C@@H](CC[C@@H](C)[C@H]1CC[C@H]2[C@@H]3[C@H](O)C[C@H]4C[C@H](CC[C@]4(C)[C@H]3CC[C@]12C)NCCCNCCCCN)OS(O)(=O)=O
Reason stopped: 
    sponsor withdrew drug.
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Locally advanced disease

                    -  No metastatic disease

          -  High-risk characteristics, meeting ≥ 1 of the following criteria:

               -  Large, hard tumor on digital exam

               -  Aggressive-appearing cancer cells on biopsy

          -  Prostate-specific antigen > 10 ng/mL

        PATIENT CHARACTERISTICS:

        Performance status

          -  0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin > 11.0 g/dL

        Hepatic

          -  Bilirubin < 2 times upper limit of normal (ULN)

          -  SGOT and SGPT < 2 times ULN

          -  PT and PTT normal

        Renal

          -  Creatinine < 1.8 g/dL

        Cardiovascular

          -  No history of ventricular arrhythmia or dysfunction

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No prior myocardial infarction

          -  No history of thromboembolic disease (e.g., deep vein thrombosis or stroke) within the
             past 12 months

          -  No other significant cardiovascular disease

        Pulmonary

          -  No pulmonary embolism within the past 12 months

          -  No exercise-limiting respiratory disease

        Other

          -  Fertile patients must use effective barrier method contraception

          -  No sexual intercourse for 6 weeks after surgery

          -  No uncontrolled diabetes

          -  No serious acute infection

          -  No other malignancy except nonmelanoma skin cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior squalamine lactate

        Chemotherapy

          -  No prior chemotherapy for prostate cancer

          -  No concurrent anticancer chemotherapy

        Endocrine therapy

          -  No concurrent systemic corticosteroids

        Radiotherapy

          -  No prior radiotherapy for prostate cancer

          -  No concurrent radiotherapy

        Surgery

          -  No prior surgery for prostate cancer

          -  No other concurrent surgery

        Other

          -  At least 6 weeks since prior and no concurrent use of over-the-counter or herbal drugs
             that have estrogenic activity

          -  No participation in another investigational study within the past 3 months

          -  No concurrent participation in another investigational study