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DOCETAXEL AND PREDNISON IN ASSOCIATION WITH METRONOMIC THERAPY WITH CICLOPHOSPHAMIDE AND CELECOXIN IN HORMONE-REFRACTORY PROSTATIC CANCER PATIENTS : PHASE II CLINICAL TRIAL WITH PHARMACODYNAMIC AND PHARMACOGENETIC EVALUATIONS - PROMET 2

DOCETAXEL AND PREDNISON IN ASSOCIATION WITH METRONOMIC THERAPY WITH CICLOPHOSPHAMIDE AND CELECOXIN IN HORMONE-REFRACTORY PROSTATIC CANCER PATIENTS : PHASE II CLINICAL TRIAL WITH PHARMACODYNAMIC AND PHARMACOGENETIC EVALUATIONS - PROMET 2

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004478-29-IT
Enrollment
Unknown
Registered
2012-09-28
Start date
2006-12-17
Completion date
Unknown
Last updated
2014-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS WITH PROSTATIC HORMONE-REFRACTORY CANCER MedDRA version: 15.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: TAXOTERE Pharmaceutical Form: Solution for infusion INN or Proposed INN: Docetaxel Concentration unit: mg milligram(s) Concentration number: 60- Trade Name: DELTACORTENE Pharmaceutical Fo

Sponsors

G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: DIAGNOSIS OF HORMONE-REFRACTORY PROSTATIC CANCER IN BIOCHIMIC AND/OR CLINIC EVIDENCE OF DISEASE PROGRESSION Are the trial subjects under 18? no Number of subjects for this age range: 0 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

Exclusion criteria: PREVIOUS CHEMOTHERAPY BUT EXTRAMUSTINE TREATMENT HEART FAILURE

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Evaluation of antitumoral activity as reduction of PSA level>50% and as objective responses by RECIST criteria Evaluation of the toxicity profile Evalution of OS Evaluation of serum levels variations of TSP-1,VEGF and sVEGFR-2 Evaluation of MRNA of VE-caderine Evaluation of expression and synthesis changing of TSP-1 and VEGF Evaluation of the most frequent genetic polymorfisms of CYP2B6,CYP2C19,CYP2C9 and CYP3A5 and find the correlation with the anti-angiogenic/antitumor observed response Quality of life and pain control;Primary end point(s): EVALUATION PFS;Main Objective: EVALUATION PFS—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026