ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer
NCT ID: NCT00415779
Last Updated: 2010-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2006-07-31
2009-07-31
Brief Summary
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Detailed Description
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Sequence A: Docetaxel on day 1 and zoledronic acid on day 2
Sequence B: Zoledronic acid on day 1 and docetaxel on day 2
Patients are enrolled sequentially in cohorts of 3 for each dose level, and a maximum of 36 patients will be enrolled.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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docetaxel
given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
zoledronic acid
2 mg IV every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
MALE
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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National Cancer Institute Naples, Italy
Principal Investigators
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Michele Caraglia, M.D.
Role: PRINCIPAL_INVESTIGATOR
Experimental Pharmacology, National Cancer Institute Naples
Alfredo Budillon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Experimental Pharmacology, National Cancer Institute Naples
Francesco Perrone, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
R. Vincenzo Iaffaioli, M.D
Role: PRINCIPAL_INVESTIGATOR
Medical Oncology B, National Cancer Institute Naples
Gaetano Facchini, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical Oncology B, National Cancer Institute Naples
Alessandro Morabito, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinical Trials Unit, National Cancer Institute Naples
Locations
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Istituto Nazionale dei Tumori
Napoli, , Italy
Ospedale Oncologico Regionale C.R.O.B. - Basilicata
Rionero in Vulture, , Italy
Countries
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Other Identifiers
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EUDRACT 2006-000426-31
Identifier Type: -
Identifier Source: secondary_id
ZANTE
Identifier Type: -
Identifier Source: org_study_id
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