ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase I trial is studying the side effects and best dose of docetaxel when given with zoledronic acid in patients with bone metastasis from prostate cancer that has not responded to hormone therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Diphosphonates; Docetaxel; Hormones; Zoledronic Acid

Criteria

Inclusion Criteria:

• Written informed consent

• Hormone refractory prostate cancer

• Stage IV disease with bone metastasis

• No immunotherapy, hormonal therapy or radiotherapy within the previous month

• Performance status < or = 2 (ECOG)

• Serum creatinine < 1.5 mg/100ml

• Serum bilirubin < or = 1.25 x UNL (upper normal limit) (or < or = 1.5 x UNL in the presence of hepatic metastases); SGOT e SGPT < or = 1.5 x UNL (or < or = 2.5 x UNL in presence of hepatic metastases)

• Left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or MUGA scan)

• Neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· Life expectancy of at least 3 months

Exclusion Criteria:

• Previous malignancies with the exception of radically treated epithelioma

• Previous chemotherapy

• Comorbidities that would, in the Investigator's opinion, contraindicate the use of the drugs in the study

• Uncontrolled Diabetes

• Severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months

• severe infection

• cerebral metastasis

• Pre-existing motor or sensory neurotoxicity > or = grade 2 according to CTC (Common Toxicity Criteria).