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INTRAPLEURAL PACLITAXEL IN PATIENTS WITH MALIGNANT PLEURAL EFFUSIONS SECONDARY TO OVARIAN CANCER AND OTHER NEOPLASMS - ND

INTRAPLEURAL PACLITAXEL IN PATIENTS WITH MALIGNANT PLEURAL EFFUSIONS SECONDARY TO OVARIAN CANCER AND OTHER NEOPLASMS - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003664-22-IT
Enrollment
Unknown
Registered
2007-06-26
Start date
2007-01-22
Completion date
Unknown
Last updated
2012-08-28

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

Conditions

MALIGNANT PLEURAL EFFUSION SECONDARY TO OVARIAN, BREAST OR LUNG CANCER MedDRA version: 9.1 Level: LLT Classification code 10027463 Term: Metastases to pleura

Interventions

Trade Name: TAXOL Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6-

Sponsors

ISTITUTO ONCOLOGICO VENETO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: NO PREVIUOS CHEMOTHERAPY, NEGATIVE PLEURAL CYTOLOGY (EXCEPT FOR MESOTELIOMA), ACTIVE INFECTIONS, NEUTROPENIA< 1500/MM3 AND PLATELETS<140000/MM3

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

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