Phase II study with pharmacokinetic and pharmacodynamic evaluations of metronomic chemotherapy with oral Vinorelbine and Dexamethasone in advanced castraction-resistant prostate cancer patients - ProMet-3

Phase 1

• Conditions: Patients with advanced metastatic prostatic carcinoma; MedDRA version: 9.1Level: LLTClassification code 10036909

• Registration Number: EUCTR2009-015116-17-IT
• Lead Sponsor: ARCO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-21
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

-Diagnosis of metastatic or locally advanced castration-resistant prostate adenocarcinoma,
-Failure of previous docetaxel-based chemotherapy or patient unable to receive chemotherapy with docetaxel
-Increasing PSA serum levels in three consecutive measuraments at least 1 week apart
-PSA serum value ≥ 2 ng/mL
-Serum Testosterone < 50 ng/dL (< 1.7 mmol/L)
-ECOG PS ≤ 2
-Life expectancy ≥ 3 months
-Adequate renal function (serum creatinine level < 1.25 upper normal limit)
-Adequate liver function (serum total bilirubin level < 1.5 upper normal limit, aspartate aminotransferasi and alanine aminotransferasi < 3 upper limit)
-Adequate bone marrow function (leukocytes > 3000/ mL, platelets > 100000/mL, haemoglobin level > 10 g/dL)
-Interruption of antiandrogen therapy at least 4-8 weeks before enrollment, without biochemical response at time of suspension, in the absence of clinical or instrumental evidence of disease progression
-Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Uncontrolled metabolic diseases or active infections
-One of the following condition in the 12 months before the enrollment:
- Miocardial infarction
- Severe or unstable angina
- Congestive heart failure
- Pulmonary embolism, stroke, transient ischemic attack
- Cardiac arrhythmias
- QT interval > 450 msec
- Coronary or periferic arterial bypass
-Uncontrolledi hyperthension
-Anticoaugulant treatment
-Brain metastases
-Second malignancies, except skin basal cell carcinoma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified