peritoneal carcinomatosis
Conditions
Interventions
Trade Name: Abraxane
Product Name: Abraxane
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: paclitaxel
Other descriptive name: PACLITAXEL ALBUMIN-BOUND
Concentration unit
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Phase I study: patients with advanced carcinomatosis from ovarian, gastric, breast, upper GI or pancreatic origin. - No concurrent taxane based systemic chemotherapy. - Phase II study: platinum resistant or refractory recurrent ovarian cancer or primary peritoneal carcinoma, FIGO stage IIIB or C. - Selected stage IV patients with very limited metastatic disease are eligible for inclusion - Age over 18 years - Adequate performance status (Karnofsky index > 60%) - Absence of intestinal or urinary obstruction - Limited size of the majority of peritoneal tumor implants ( 100.000/µl * Hemoglobin > 9g/dl * Neutrophil granulocytes > 1.500/ml * Blood coagulation parameters within normal range - Absence of alcohol and/or drug abuse - No other concurrent malignant disease - Written informed consent 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 53 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: - Concurrent systemic taxane therapy until three weeks before the first experimental treatment - Pregnancy or breast feeding. Women who can become pregnant must ensure effective contraception - Active bacterial, viral or fungal infection - Active gastro-duodenal ulcer - Parenchymal liver disease (any stage cirrhosis) - Uncontrolled diabetes mellitus - Psychiatric pathology affecting comprehension and judgement faculty - General or local (abdominal) contra-indications for laparoscopic surgery - Documented intolerance or allergy to paclitaxel (Taxol or Abraxane)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the safety and efficacy of IV Taxol combined with repeated pressurized intraperitoneal aerosol therapy (PIPAC) using albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) in a multicentre, multinational phase I/II trial.;Secondary Objective: not applicable;Primary end point(s): Phase I: Maximally tolerated dose of Abraxane, administered every four weeks using intraperitoneal laparoscopy-assisted aerosolisation (PIPAC). Phase II: Progression free survival, measured from the day of randomization.;Timepoint(s) of evaluation of this end point: Phase I: after every study drug administration Phase II: from the day of randomization until the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: - Surgical morbidity and mortality of laparoscopy - Technical failure rate - Pathological response rate - Pharmacokinetic/Pharmacodynamic analysis - Quality of life at 2 and 6 months after third PIPAC Phase II: - Surgical morbidity and mortality of laparoscopy - Technical failure rate - Pathological response rate - Overall survival - Disease free survival;Timepoint(s) of evaluation of this end point: - All endpoints: after each visit until end of study - Quality of life at 2 and 6 months after first study drug administration | — |
Countries
Belgium, Denmark, France, Germany, Italy, Switzerland
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed