Clinical trial NCT00293371 (phase 1/phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: docetaxel, prednisone, vatalanib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, ClC1=CC=C(NC2=NN=C(CC3=CC=NC=C3)C3=CC=CC=C23)C=C1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically documented adenocarcinoma of the prostate

          -  Progressive, systemic (metastatic) disease despite castrate levels of testosterone due
             to orchiectomy or luteinizing-hormone releasing hormone (LHRH) agonist, meeting 1 of
             the following criteria:

               -  Measurable disease, defined as any lesion that can be accurately measured in at
                  least 1 dimension ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan
                  or MRI

               -  Nonmeasurable disease with PSA ≥ 5 ng/mL

                    -  Bone lesions

                    -  Pleural or pericardial effusions, ascites

                    -  CNS lesions, leptomeningeal disease

                    -  Irradiated lesions, unless progression documented after radiotherapy

                    -  No PSA ≥ 5 ng/mL as only evidence of disease

               -  PSA evidence for progressive prostate cancer consists of a PSA level ≥ 5 ng/mL
                  that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart

          -  Castrate levels of testosterone (< 50 ng/dL) must be maintained

               -  If no prior orchiectomy, patients must remain on testicular androgen suppression
                  (e.g., with an LHRH analogue)

          -  Patients receiving an antiandrogen as part of primary androgen ablation must
             demonstrate disease progression after discontinuation of antiandrogen

               -  Disease progression after antiandrogen withdrawal is defined as 2 consecutive
                  rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft
                  tissue progression

                    -  For patients receiving flutamide or megestrol acetate, at least 1 of the PSA
                       values must be obtained 4 weeks or more after flutamide/megestrol acetate
                       discontinuation

                    -  For patients receiving bicalutamide or nilutamide, at least 1 of the PSA
                       values must be obtained 6 weeks or more after antiandrogen discontinuation

               -  If improvement after antiandrogen withdrawal is noted, disease progression must
                  be established

          -  No pleural effusion or ascites that causes respiratory compromise ( ≥ grade 2 dyspnea)

          -  No history of CNS disease, including primary brain tumor, seizures, or carcinomatous
             meningitis

        PATIENT CHARACTERISTICS:

          -  Fertile patients must use effective barrier contraception during and for 3 months
             after completion of study treatment

          -  Karnofsky performance status ≥ 60%

          -  Life expectancy > 12 weeks

          -  Granulocyte count > 1,500/mm^3

          -  Platelet count > 75,000/mm^3

          -  Hemoglobin > 8.0 g/dL

          -  Creatinine < 1.5 times upper limit of normal (ULN)

          -  Bilirubin < 1.5 times ULN

          -  SGOT/SGPT < 1.5 times ULN

          -  Urinalysis ≤ 1+ proteinuria based on dipstick reading OR 2+ proteinuria on dipstick
             reading AND total urinary protein ≤ 3,500 mg on 24 hour urine collection and
             creatinine clearance ≥ 50 mL/min on a 24-hour urine collection

          -  No impairment of gastrointestinal (GI) function or GI disease that may affect or alter
             absorption of vatalanib (i.e., malabsorption syndromes)

          -  No myocardial infarction or significant change in anginal pattern within the last 6
             months, symptomatic congestive heart failure (New York Heart Association class III or
             IV), or uncontrolled cardiac arrhythmia

          -  No pre-existing grade 3 or 4 clinical peripheral neuropathy

          -  No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80

          -  No deep vein thrombosis or pulmonary embolus within the past year

          -  No poorly controlled diabetes (fasting blood glucose > 250) despite optimization of
             medical therapy

          -  No labile or poorly controlled hypertension (systolic blood pressure > 160 mm Hg,
             diastolic blood pressure > 90 mm Hg) despite maximal management with
             anti-hypertensives

          -  No serious uncontrolled, concurrent medical illness, including ongoing or active
             infection

               -  Patients on Suppressive antibiotic therapy for chronic urinary tract infection
                  are eligible

          -  No psychiatric illness or social situation that would limit compliance with treatment

          -  No "currently active" second malignancy other than nonmelanoma skin cancers

               -  Not considered "currently active" if competed therapy and at < 30% risk of
                  relapse

          -  No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the
             lung

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No grapefruit or grapefruit juice during study treatment

          -  No history of gastrectomy/small bowel resection

          -  At least 4 weeks since prior hormonal therapy, including ketoconazole,
             aminoglutethimide, systemic steroids (any dose), and megestrol acetate (any dose)

          -  At least 4 weeks since prior drug or herbal product known to decrease PSA levels
             (e.g., finasteride, saw palmetto, or PC-SPES)

          -  At least 4 weeks since prior major surgery and fully recovered

          -  At least 4 weeks since prior radiation therapy and fully recovered

          -  At least 8 weeks since the last dose of prior strontium chloride Sr 89 or samarium Sm
             153 lexidronam pentasodium

          -  Patients receiving bisphosphonate therapy prior to initiating protocol treatment must
             have received bisphosphonates for at least the past month

               -  No bisphosphonate initiation for 1 month prior to and during study treatment

          -  No prior systemic chemotherapy for prostate cancer

          -  No prior antiangiogenic agents (thalidomide, bevacizumab)

          -  No other concurrent chemotherapy, investigational agents, radiotherapy (including
             palliative), or biologic therapy

          -  No biologic therapy or immunotherapy ≤ 4 weeks prior to study treatment

          -  No more than 1 prior therapy with an investigational agent, completed ≥ 4 weeks prior
             to study treatment

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent therapeutic warfarin or similar oral anticoagulant that is metabolized
             by the cytochrome p450 system

               -  Heparin is allowed

          -  No other concurrent hormonal therapy except for the following:

               -  Steroids for adrenal failure

               -  Hormones for nondisease-related conditions (e.g., insulin for diabetes)

               -  Intermittent dexamethasone