Cancer of the prostate is the most commonly diagnosed neoplasm in men in the United States after skin cancer. In 2002, over 189,000 new cases were diagnosed in United States representing 30% of all new cancer diagnoses in men comparable to the incidence of breast cancer in women. Patients with metastatic androgen-independent prostate cancer have a progressive and morbid disease with a median survival of 10 to 12 months.
Conditions
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •Patients with histologically proven adenocarcinoma of the prostate •Patients must have castrate levels of testosterone (serum testosterone = 50ng/ml) by either being on androgen ablation therapy with a LHRH agonist or have had prior orchiectomy. •Progressive disease is defined as: a minimum of three consecutives elevations in PSA according to the PSA working Group (with the last value > 5 ng/mL) and/or new metastatic lesions on bone scan; and/or new or progressive measurable disease on computer tomography scan or magnetic resonance image. Bone scan findings alone are not adequate to define progression of measurable disease. Patients previously treated with an antiandrogen must have disease progression documented after antiandrogen withdrawal. Minimum evidence of progression is a 25% increase over a reference value of PSA, provided that the increase is a minimum of 5 ng/mL. The first increase in PSA should occur at a minimum of one week from the reference value. This increase should then be confirmed by a second increase in PSA at least 1 week later. Patients previously treated with an antiandrogen must have disease progression documented after antiandrogen withdrawal. •Patients in whom flutamide, nilutamide, megestrol acetate, diethylstilbestrol, aminoglutethimide and ketoconazole has been recently withdrawn must demonstrate progression of disease at least four weeks beyond the discontinuation of such agents .Six weeks are required if prior treatment was bicatulamide. •Chemotherapy-naïve patients.(unlimited prior regimens of hormonal therapy) •Age =18 years •WHO Performance Status of 0,1 or 2 •Adequate hematologic , hepatic and renal functions . •Full recovery from the effect of any prior surgery or radiation therapy. •Current treatment with steroids is permitted provided that the patients is stable for at least 2 weeks before start of study, at, or less than, an equivalent daily dose of 10mg prednisone. •Concurrent biphosphonates can be allowed provided treatment was initiated at least 4 weeks prior to study entry Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients who received palliative radiation therapy to tumors located centrally less than 4 weeks prior to planned enrollment date. Radiotherapy limited to no more than 25% of the bone marrow. •No prior strontium chloride (SR 89) or Samarium 153 lexidronam pentasodium •Known brain metastases. •Peripheral neuropathy > grade1. •Unresolved diarrhea of any grade in the last 7 days prior to study entry. •Significant cardiovascular disease (New York Heart Association Class III or IV congestive heart failure, active angina pectoris and /or myocardial infarction within the last 6 months. •Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin (1mg or less daily) for maintenance of indwelling lines or ports. •Patients who have gone under surgery for any cause less than 4 weeks prior to study entry. •Patients with the presence of active or suspected acute or chronic uncontrolled infection and uncontrolled diabetes. •A concurrent active malignancy other than curatively treated non melanoma skin cancer. •A history of non compliance to medical regimen or inability or unwillingness to return for all scheduled visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the antitumor response of patupilone administered I.V. at 10 mg/m2 once every three weeks and docetaxel administered at 75 mg/m2 once every three weeks as defined by the effect of treatment on PSA concentration. The PSA decrease will be documented in accordance with the consensus guidelines of the PSA working group. ;Secondary Objective: •To evaluate the measurable soft tissue disease response for both regimens (RECIST) •To compare the antitumor response determined by PSA response rate and safety profile between patupilone and docetaxel •To determine time to measurable and non-measurable disease progression (RECIST) •To determine time to PSA progression (date of randomization to the date of PSA progression) •To determine the duration of PSA response (date of the first 50% decline in PSA until PSA increases by 50% above the nadir) •To determine the duration of response for measurable disease •To evaluate difference in terms of efficacy, safety and clinical benefit between the two treatment arms •To evaluate patient-reported outcomes including quality of life (QoL) and symptom assessment of patients •To investigate the relationship between PK (Cmin) of patupilone in HRPC patients and clinical outcome. ;Primary end point(s): Response in terms of PSA decrease measured according to the PSA Working Group guidelines. For measurable disease response will be measured according to the RECIST criteria. | — |
Countries
Belgium, Germany, Italy, Spain
Outcome results
None listed