## Protocol Section
### Identification Module
**NCT ID:** NCT00415779

**Acronym:** ZANTE

**Brief Title:** ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

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

#### Organization Study ID Info
**ID:** ZANTE
#### Organization
**Class:** OTHER
**Full Name:** National Cancer Institute, Naples
#### Secondary ID Infos
**ID:** EUDRACT 2006-000426-31
### Status Module
#### Completion Date
**Date:** 2009-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-02-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-02-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Start Date
**Date:** 2006-07

**Status Verified Date:** 2010-02

#### Study First Post Date
**Date:** 2006-12-25
**Type:** ESTIMATED
**Study First Submit Date:** 2006-12-22
**Study First Submit QC Date:** 2006-12-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Cancer Institute, Naples

#### Responsible Party

**Old Name Title:** Francesco Perrone, Director Clinical Trials Unit

**Old Organization:** National Cancer Institute Naples, Italy

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Metastatic Prostate Cancer

**Keywords:**

- hormone refractory

- bone metastasis

- chemotherapy

- biphosphonates

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2

**Name:** docetaxel

**Type:** DRUG

#### Intervention 2

**Description:** 2 mg IV every 2 weeks

**Name:** zoledronic acid

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** 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

#### Secondary Outcomes

**Measure:** to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies

**Time Frame:** every 2 weeks for 6 cycles

**Measure:** to determine which administration sequence of the combination permits a higher dosage of docetaxel

**Time Frame:** every 2 weeks for 6 weeks

**Measure:** to describe the toxicity of the combination of the two drugs

**Time Frame:** every 2 weeks

**Measure:** 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

**Measure:** to describe the antitumor activity of the two drug association

**Time Frame:** every 12 weeks

### Eligibility Module

**Eligibility 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).

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Napoli

**Country:** Italy

**Facility:** Istituto Nazionale dei Tumori

**Zip:** 80131

**Location 2:**

**City:** Rionero in Vulture

**Country:** Italy

**Facility:** Ospedale Oncologico Regionale C.R.O.B. - Basilicata

#### Overall Officials

**Official 1:**

**Affiliation:** Experimental Pharmacology, National Cancer Institute Naples

**Name:** Michele Caraglia, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Experimental Pharmacology, National Cancer Institute Naples

**Name:** Alfredo Budillon, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** National Cancer Institute Naples, Italy; Director Clinical Trials Unit

**Name:** Francesco Perrone, M.D., Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Medical Oncology B, National Cancer Institute Naples

**Name:** R. Vincenzo Iaffaioli, M.D

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Medical Oncology B, National Cancer Institute Naples

**Name:** Gaetano Facchini, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Clinical Trials Unit, National Cancer Institute Naples

**Name:** Alessandro Morabito, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M1668

- Name: Docetaxel

- Relevance: HIGH

- As Found: Physical

- ID: M1699

- Name: Zoledronic Acid

- Relevance: HIGH

- As Found: Lymphoblastic

- ID: M7346

- Name: Diphosphonates

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077211

- Term: Zoledronic Acid

- ID: D000077143

- Term: Docetaxel

### Misc Info Module

- Version Holder: 2024-05-24
