Docetaxel, Prednisone, and Vatalanib in Treating Patients With Advanced Prostate Cancer

Inclusion 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