Phase I/II study investigating increasing doses of bevacizumab in patients with malignant effusio

• Conditions: Malignant effusion in cancer patients requiring frequent centesis, at least two within six weeks

• Registration Number: EUCTR2006-003230-15-AT
• Lead Sponsor: niversity Clinic Internal Medicine I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-30
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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