ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

National Cancer Institute, Naples

Status and phase

Completed

Phase 1

Conditions

Metastatic Prostate Cancer

Treatments

Drug: docetaxel

Drug: zoledronic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT00415779

EUDRACT 2006-000426-31

ZANTE

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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).