NCT00415779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2006

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

2.4 years

First QC Date

December 22, 2006

Last Update Submit

February 23, 2010

Conditions

Metastatic Prostate Cancer

Keywords

hormone refractorybone metastasischemotherapybiphosphonates

Outcome Measures

Primary Outcomes (1)

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

    every 2 weeks for up to 3 cycles

Secondary Outcomes (5)

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

    every 2 weeks for 6 cycles

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

    every 2 weeks for 6 weeks

  • to describe the toxicity of the combination of the two drugs

    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

    every 12 weeks

  • to describe the antitumor activity of the two drug association

    every 12 weeks

Interventions

docetaxelDRUG

given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2

zoledronic acidDRUG

2 mg IV every 2 weeks

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto Nazionale dei Tumori

Napoli, 80131, Italy

Location

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

Rionero in Vulture, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelZoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 25, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2008

Study Completion

July 1, 2009

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

IT(2)