PHASE II CLINICAL AND PHARMACOKINETIC STUDY OF PEGYLATED LIPOSOMAL DOXORUBICIN AND GEMCITABINE IN ADVANCED OVARIAN CARCINOMA - CAGEM

• Conditions: OVARIAN ADENOCARCINOMA; MedDRA version: 6.1Level: PTClassification code 10061328

• Registration Number: EUCTR2005-005725-64-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 97

Inclusion Criteria

1. AGE MORE THAN 18 2. PATHOLOGICALLY CONFIRMED DIAGNOSIS OF RELAPSING OVARIUM ADENOCARCINOMA 3. AT LEAST ONE CHEMOTHERAPY REGIMEN 4. ECOG PS MINOR OR EQUAL THAN 2 5. LIFE EXPECTANCY MORE THAN 12 WEEKS 6. LVEF MORE THAN 50 7. NO OTHER MALIGNANCIES 8. NORMAL BLOOD, HEPATIC AND RENAL FUNCTIONS
Are the trial subjects under 18? no
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

1. PREGNANCY AND BREAST FEEDING; 2. ANY PREVIOUS TREATMENT WITH ANTHRACYCLINES AND GEMCITABINE; 3. HYPERSENSIBILITY TO CREMOPHOR EL-BASED PRODUCTS; 4. UNCONTROLLED INFECTIOUS DISEASES; 5. ANY RADIOTHERAPY REGIMEN DURING THE LAST 4 WEEKS; 6. CNS SYMPTOMATIC METASTASES

Study & Design

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