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ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00415779
First received: December 22, 2006
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Metastatic Prostate Cancer
 Drug: docetaxel
Drug: zoledronic acid
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies [ Time Frame: every 2 weeks for 6 cycles ] [ Designated as safety issue: Yes ]
  • to determine which administration sequence of the combination permits a higher dosage of docetaxel [ Time Frame: every 2 weeks for 6 weeks ] [ Designated as safety issue: Yes ]
  • to describe the toxicity of the combination of the two drugs [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • to describe the antitumor activity of the two drug association [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415779

Locations
Italy
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
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: 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
  More Information

No publications provided

Responsible Party: Francesco Perrone, Director Clinical Trials Unit, National Cancer Institute Naples, Italy
ClinicalTrials.gov Identifier: NCT00415779     History of Changes
Other Study ID Numbers: ZANTE, EUDRACT 2006-000426-31
Study First Received: December 22, 2006
Last Updated: February 23, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
hormone refractory
bone metastasis
chemotherapy
biphosphonates

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Docetaxel
 Zoledronic acid
Diphosphonates
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013