E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hormone refraktory prostate cancer |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to evaluate - whether CEC/CEP spikes induced by MTD docetaxel are suppressed by sunitinib in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess whether - whether docetaxel/sunitinib increase response rate and length of treatment holidays relative to docetaxel monotherapy - CEC/CEP remain suppressed by sunitinib maintenance therapy relative to patients receiving no sunitinib during chemotherapy treatment holidays - suppression of CEC/CEP by sunitinib co-treatment correlates with response rate and prolonged treatment holidays relative to patients receiving no sunitinib - whether serum angiogenesis biomarkers (i.e. VEGF, VEGFR, TSP1) and tumor biomarkers (i.e. Visfatin, SphP1) are suppressed by co- treatment with sunitinib and correlate with response rate and treatment holidays - whether treatment by sunitinib/docetaxel and sunitinib maintenance therapy in safe and tolerable
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed written informed consent - Male patients 18 years of age - WHO performance status of 0-2. - Histologically proven prostate adenocarcinoma. - All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression. - Measurable and/or evaluable progressive disease, which is defined as one of the following three criteria: • 25% increase in bidimensionally measurable soft tissue metastases • Appearance of new metastatic lesions (proven by CT scan,X-ray or bone scan) • PSA level at least 10 ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart - Castrate level of testosterone (<50ng/dl) in all patients. Patients with medical castration with LH-RH analogue must continue analogue. - If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization. - Baseline LVEF 50 % measured by echocardiography or MUGA scan - Continuation of biphosphonates allowed. - Adequate bone marrow reserve: WBC ≥ 3.5 x 109/L, ANC ≥ 1.5 x 109/L, Hb ≥ 10 g/dl, platelets ≥ 100 x 109/L - Adequate liver function: Bilirubin ≤ 1, 5 x UNL (upper normal level), ASAT and ALAT ≤ 1,5 x UNL - Adequate renal function: creatinine ≤ 1,5 times the ULN
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E.4 | Principal exclusion criteria |
Known brain metastases. - Peripheral neuropathy > grade 1 (according to NCI-CTC version 3.0). - Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years. - Prior chemotherapy, radiotherapy, involving more than 25% of bone marrow producing area. (Prior use of Estramustine phosphate is allowed). - Active infection or known HIV. - Other serious illness or medical condition: unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry, active uncontrolled infection, peptic ulcer, unstable diabetes mellitus or other contraindications for the use of prophylactic corticosteroid medication. - Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening. - Presence of any psychological, familial, sociological, geographical condition hampering compliance with the study protocol and follow up schedule.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |