Clinical trial · Interventional
ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer
Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
NCT00415779CI-TRIAL-00003191ZANTEcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules
- timeFrame
- every 2 weeks for up to 3 cycles
Secondary outcomes (5)
- measure
- to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies
- timeFrame
- every 2 weeks for 6 cycles
- measure
- to determine which administration sequence of the combination permits a higher dosage of docetaxel
- timeFrame
- every 2 weeks for 6 weeks
- measure
- to describe the toxicity of the combination of the two drugs
- timeFrame
- every 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.