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

Phase 1
18 Years
Not Enrolling
Metastatic Prostate Cancer

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Trial Information

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

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.

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

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

every 2 weeks for up to 3 cycles

Safety Issue:


Principal Investigator

Michele Caraglia, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Experimental Pharmacology, National Cancer Institute Naples


Italy: Ethics Committee

Study ID:




Start Date:

July 2006

Completion Date:

July 2009

Related Keywords:

  • Metastatic Prostate Cancer
  • hormone refractory
  • bone metastasis
  • chemotherapy
  • biphosphonates
  • Prostatic Neoplasms