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

February 23, 2010 updated by: National Cancer Institute, Naples

Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori
      • Rionero in Vulture, Italy
        • Ospedale Oncologico Regionale C.R.O.B. - Basilicata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
every 2 weeks for up to 3 cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies
Time Frame: every 2 weeks for 6 cycles
every 2 weeks for 6 cycles
to determine which administration sequence of the combination permits a higher dosage of docetaxel
Time Frame: every 2 weeks for 6 weeks
every 2 weeks for 6 weeks
to describe the toxicity of the combination of the two drugs
Time Frame: every 2 weeks
every 2 weeks
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
every 12 weeks
to describe the antitumor activity of the two drug association
Time Frame: every 12 weeks
every 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • 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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 22, 2006

First Posted (Estimate)

December 25, 2006

Study Record Updates

Last Update Posted (Estimate)

February 24, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZANTE
  • EUDRACT 2006-000426-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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