Malignant effusion in cancer patients requiring frequent centesis, at least two within six weeks
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Intravenous infusion
Sponsors
University Clinic Internal Medicine I
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients with a histologically proven diagnosis of malignant disease and malignant effusion requiring frequent centesis (at least 2 centeses within 6 weeks prior to study entry) Succesful centesis prior to study entry Age between 18 years – 75 years Eastern Cooperative Oncology Group (ECOG) Performance Status £ 4 Adequate liver function: bilirubin £ 1,5 times the upper limit of normal (ULN) or £ 2 x ULN in patients with liver metastasis; alanine transaminase (ALT) and aspartate transaminase (AST) £ 2 x ULN or £ 3 x ULN in patients with liver metastasis Adequate renal function (creatinine £ 1,5 times the ULN, creatinine clearance = 60 ml/min) Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the trial Negative urinary or serum pregnancy test in women with intact reproductive organs and women less than one year after the menopause Life expectancy of at least 3 months Signed 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Treatment with any investigational agent within 4 weeks before enrolment into the study Concomitant cytotoxic chemotherapy or any other anti-tumor therapy, unless malignant effusion has evolved or worsened during this specific therapy. Any prior chemotherapy is allowed, but has to be finished or stopped at least 4 weeks prior to study entry Prior treatment with bevacizumab within 4 weeks prior to study entry Major surgery within 6 weeks before study enrolment Radiotherapy within the last 2 weeks before study enrolment or no recovery from toxic effects of radiotherapy Pregnant or lactating women Serious uncontrolled infections (bacterial or viral). New York Heart Association (NYHA) class IV congestive heart failure History of documented poorly controlled hypertension; clinically significant valvular heart disease; high risk uncontrolled arrhythmias Other serious illness or medical condition incompatible with the study treatment at the discretion of the investigator History of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or adversely affecting compliance to study drugs Unwilling or unable to comply with the requirements of the protocol and visit schedule for the duration of the study Coagulation disorder (Normotest < 50%) or severe thrombocytopenia (< 50 G/l) Active bleeding Patients with Ovarian cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this phase I/II study is to investigate the efficacy and the dose/response relationship of bevacizumab in patients with malignant and non-malignant effusions that require frequent centesis. ;Secondary Objective: Safety of bevacizumab ;Primary end point(s): The primary endpoint of this study is the centesis free interval (CFI) as compared to the pretreatment CFI. | — |
Countries
Austria
Outcome results
None listed