ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

Metastatic Prostate Cancer Clinical Trial

— ZANTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415779
• Other study ID #: ZANTE
• Secondary ID: EUDRACT 2006-000
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2006
• Last updated: February 23, 2010
• Start date: July 2006
• Est. completion date: July 2009

Study information

• Verified date: February 2010
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel
given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
• zoledronic acid
2 mg IV every 2 weeks

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori	Napoli
Italy	Ospedale Oncologico Regionale C.R.O.B. - Basilicata	Rionero in Vulture

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies		every 2 weeks for 6 cycles	Yes
Secondary	to determine which administration sequence of the combination permits a higher dosage of docetaxel		every 2 weeks for 6 weeks	Yes
Secondary	to describe the toxicity of the combination of the two drugs		every 2 weeks	Yes
Secondary	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	No
Secondary	to describe the antitumor activity of the two drug association		every 12 weeks	No