None listed
Conditions
Interventions
Group 1 Type of group
ZD4054 10 mg in combination with docetaxel for 10 cycles of 21 days each
Group name:Group 2 Type of group
ZD4054 matched placebo in combination with docetaxel for 10 cycles of 21 days each
Sponsors
ASTRAZENECA UK LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: • Prevision of informed consent • Male, aged 18 years or elder • Histological or cytological confirmation of adenocarcinoma of the prostate • Documented evidence of bone metastasis on bone scan. Patients must have disease involvement <75% of the spine, pelvis and ribs in the anteroposterior (AP) or posteroanterior (PA) view. Patients with <3 lesions seen on bone scan will require a CT scan, MRI or x-ray to confirm • Biochemical progression of prostate cancer, documented while the patient is castrate • Surgically castrated or continuously medically castrated with serum testosterone <2.4 nmol/L (70 ng/dL). • World Health Organization (WHO) performance status O - 1 (see Appendix E). • Life expectancy of 3 months or more.
Exclusion criteria
Exclusion criteria: • Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment • Prior cytotoxic chemotherapy (such as paclitaxel, docetaxel and mitoxantrone) for the treatment of recurrent prpstate cancer (prior estramustine therapy is allowed), as well as other targeted cancer therapies (such as EGF, EGFR, VEGF and VEGFR) • Systemic radionuclide therapy (ie, strontium chloride Sr^^, ^^^Relabeled HEDP, or Sm-EDTMP pentasodium) within 12 weeks of starting study treatment • Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine, phenobarbitone, St John*s Wort) within 2 weeks of starting study treatment. Dexamethasone is a known inducer of CYP2D6 and CYP3A4 but is acceptable for this study when used as part of the standard docetaxel regime • Use of systemic retinoids within 2 weeks of starting study treatment • Have received investigational drug in another clinical study of anti-cancer therapy, within 4 weeks of starting study treatment • Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists • Acute or evolving spinal cord compression or neurological symptoms or signs consistent with this. If a patient has neurologic symptoms, an MRI must be performed that demonstrates no impending or actual spinal cord compression. Stable, previously treated patients are allowed • Symptomatic peripheral neuropathy of CTCAE grade 2 or higher • Known or suspected central nervous system metastases. • History of past or current epilepsy, epilepsy syndrome, or other seizure disorder • Stage II, III or IV cardiac failure (classified according to New York Heart Association (NYHA) classification) or myocardial infarction within 6 months prior to study entry • QT interval corrected for heart rate eg, by Bazett´s correction >470 msec • Previous history or presence of another malignancy within the preceding 5 years except treated squamous/basal cell carcinoma of the skin • In the opinion of the investigator, any evidence of severe or imcontrolled systemic disease, (eg, currently unstable or uncompensated respiratory, cardiac, hepatic or renal disease) or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study • Absolute Neutrophil Count (ANC) 1.5 times the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert´s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology), who will be allowed in consultation with their physician • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN or 5 times the ULN in the presence of liver metastases • Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance • Patients who discontinue after randomization cannot be re-enrolled. Patients who fail to meet the inclusion/exclusion criteria may be reconsidered once for participation in the study. Patients who are re-enrolled must be re-consented and will be assigned a new enrolment number • Involvement in the planning and conduct of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as time to death (from randomisation) from any cause. Measure:Overall survival Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Pain due to metastasis that has an increase in the level of pain ffom baseline (a movement from no/mild to moderate pain or moderate to severe pain) to a minimum score of 5 points in the worst pain Item of the Brief Pain Inventory (BPI), with no decrease in analgesic use. Measure:The initiation of opiate medication or an increase ffom baseline of analgesic use of at least 25% for a duration of 1 week or more with or without a change in BPI score. Timepoints:1 week ; Outcome name:Decrease of at least 2 points from baselme in patients who had a BPI score of >2 at baseline in the absence of increased analgesic use OR a decrease from baseline of analgesic use of at least 25% for a duration of 1 week or more without an increase in BPI score Measure:Decrease in worst pain item of the Brief Pain Inventory (BPI) Timepoints:1 week ; Outcome name:As recorded by the FWB domain of the FACT-P and the Total FACT-P score Measure:Functional well being (FWB) Timepoints:During treatment | — |
Countries
Finland, France, Germany, Hungary, Italy, Netherlands, Peru, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactCarmen Catalina Tueros
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed