AzTrials
AzTrials

Metastatic Prostate CancerPhase 1ZANTENCT00415779

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

A Phase 1 study testing docetaxel and zoledronic acid in people with Metastatic Prostate Cancer, run by National Cancer Institute, Naples at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
docetaxel and zoledronic acid
Type of treatment
Injection or infusion
How many people
36 participants
Where
2 sitesItaly
Study dates
Jul 2006to Jul 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Istituto Nazionale dei Tumori

    Naples, 80131

  • Ospedale Oncologico Regionale C.R.O.B. - Basilicata

    Rionero in Vulture

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Keywords
hormone refractory, bone metastasis, chemotherapy, biphosphonates
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules

    Measured: every 2 weeks for up to 3 cycles

Secondary outcomes (5)

  1. to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies

    Measured: every 2 weeks for 6 cycles

  2. to determine which administration sequence of the combination permits a higher dosage of docetaxel

    Measured: every 2 weeks for 6 weeks

  3. to describe the toxicity of the combination of the two drugs

    Measured: 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

    Measured: every 12 weeks

  5. to describe the antitumor activity of the two drug association

    Measured: every 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionDec 2008
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415779
Sponsor's protocol ID
ZANTE
Other IDs
EUDRACT 2006-000426-31
Acronym
ZANTE
Status last verified
Feb 2010
First submitted
22 Dec 2006
Last updated
24 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing docetaxel and zoledronic acid in people with Metastatic Prostate Cancer, run by National Cancer Institute, Naples at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00415779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in