INTRAPLEURAL PACLITAXEL IN PATIENTS WITH MALIGNANT PLEURAL EFFUSIONS SECONDARY TO OVARIAN CANCER AND OTHER NEOPLASMS - ND
- Conditions
- MALIGNANT PLEURAL EFFUSION SECONDARY TO OVARIAN, BREAST OR LUNG CANCERMedDRA version: 9.1Level: LLTClassification code 10027463Term: Metastases to pleura
- Registration Number
- EUCTR2007-003664-22-IT
- Lead Sponsor
- ISTITUTO ONCOLOGICO VENETO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
SIGNED INFORMED CONSENT, CARCINOMATOUS PLEURITIS ORIGINATING IN OVARIAN, BREAST AND LUNG CANCER, PREVIOUS CHEMOTHERAPY AS FIRST LINE TREATMENT, NO PREVIUOS INTRAPLEURAL CHEMOTHERAPY, SUFFICIENT BONE MARROW RESERVE; AST/LT NOT TWICE AS MUCH OF STANDARD VALUE, REGULAR RENAL FUNCTION.
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
NO PREVIUOS CHEMOTHERAPY, NEGATIVE PLEURAL CYTOLOGY (EXCEPT FOR MESOTELIOMA), ACTIVE INFECTIONS, NEUTROPENIA< 1500/MM3 AND PLATELETS<140000/MM3
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: PERCENTAGE OF EFFICACY;Secondary Objective: P53 EXPRESSION STUDY IN ORDER TO CONFIRM THE RELATIONSHIP BETWEEN ITS OVEREXPRESSION AND THE BETTER CLINICAL RESULT, EVALUATION QUALITY OF LIFE;Primary end point(s): TO EVALUATE THE PERCENTAGE OF EFFICACY
- Secondary Outcome Measures
Name Time Method