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ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer (ZANTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415779
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : February 24, 2010
Information provided by:
National Cancer Institute, Naples

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: docetaxel Drug: zoledronic acid Phase 1

Detailed Description:

Docetaxel has been used alone and in combination with other anti-cancer therapies in the treatment of hormone refractory metastatic prostate cancer. Zoledronic acid has been used in the treatment of bone metastasis from prostate cancer. This is a study of the combination of these two agents. The Zante study will test a dose escalation of docetaxel in association with a predetermined dose of zoledronic acid (2 mg), given every 14 days for a minimum of 6 and maximum of 12 cycles.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
Study Start Date : July 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: docetaxel
    given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
  • Drug: zoledronic acid
    2 mg IV every 2 weeks

Primary Outcome Measures :
  1. to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules [ Time Frame: every 2 weeks for up to 3 cycles ]

Secondary Outcome Measures :
  1. to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies [ Time Frame: every 2 weeks for 6 cycles ]
  2. to determine which administration sequence of the combination permits a higher dosage of docetaxel [ Time Frame: every 2 weeks for 6 weeks ]
  3. to describe the toxicity of the combination of the two drugs [ Time Frame: every 2 weeks ]
  4. to describe the effects of the combination of the two drugs on biologic parameters: angiogenetic factors, cytokines, differential neuroendocrine markers, serum markers of osteolysis [ Time Frame: every 12 weeks ]
  5. to describe the antitumor activity of the two drug association [ Time Frame: every 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415779

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Istituto Nazionale dei Tumori
Napoli, Italy, 80131
Ospedale Oncologico Regionale C.R.O.B. - Basilicata
Rionero in Vulture, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
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Principal Investigator: Michele Caraglia, M.D. Experimental Pharmacology, National Cancer Institute Naples
Principal Investigator: Alfredo Budillon, M.D. Experimental Pharmacology, National Cancer Institute Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Principal Investigator: R. Vincenzo Iaffaioli, M.D Medical Oncology B, National Cancer Institute Naples
Principal Investigator: Gaetano Facchini, M.D. Medical Oncology B, National Cancer Institute Naples
Principal Investigator: Alessandro Morabito, M.D. Clinical Trials Unit, National Cancer Institute Naples
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Responsible Party: Francesco Perrone, Director Clinical Trials Unit, National Cancer Institute Naples, Italy Identifier: NCT00415779    
Other Study ID Numbers: ZANTE
EUDRACT 2006-000426-31
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010
Keywords provided by National Cancer Institute, Naples:
hormone refractory
bone metastasis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Zoledronic Acid
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs