ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

Sponsor

National Cancer Institute, Naples (Other)

Overall Status

Completed

CT.gov ID

NCT00415779

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Cancer	Drug: docetaxel Drug: zoledronic acid	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jul 1, 2009

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Istituto Nazionale dei Tumori	Napoli		Italy	80131
2	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