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Status:

COMPLETED

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

Lead Sponsor:

National Cancer Institute, Naples

Conditions:

Metastatic Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE1

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 thera...

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 b...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2009

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00415779

Start Date

July 1 2006

End Date

July 1 2009

Last Update

February 24 2010

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Istituto Nazionale dei Tumori

Napoli, Italy, 80131

2

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

Rionero in Vulture, Italy