Status:
COMPLETED
Bevacizumab as a Palliative Treatment for Patients With Symptomatic Malignant Ascites Due to Advanced-stage Gastrointestinal Cancers
Lead Sponsor:
AIO-Studien-gGmbH
Conditions:
Malignant Ascites
Gastrointestinal Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Malignant ascites represents a severe clinical problem for physicians and patients being confronted with this common symptom of advanced-stage gastrointestinal cancer. Unfortunately, there is no stand...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Written informed consent has been obtained prior to inclu¬sion into the study
- Patient is capable and willing to comply with the study
- Histologically confirmed esophageal, gastric, pancreatic, cholangiocellular, hepatocellular, or colorectal carcinoma
- Cytologically confirmed ascites OR diagnosis of an exsudate (total protein in ascites \> 30 g/l) clinically suggestive for malignant ascites OR morphological diagnosis of peritoneal carcinosis by CT , MRT or ultrasound
- Ascites clinically judged as not responsive to conventional systemic therapies for primary malignancy
- Ascites clinically judged as not responsive to diuretics
- At the time of inclusion paracentesis required at least twice within past 4 weeks.
- Before inclusion of the patient into the study, a 4-week screening period will allow for a stringent evaluation of the patient regarding fulfillment of inclusion and exclusion criteria. Importantly, no treatments for malignant ascites other than paracentesis and diuretics are allowed during the 4-week screening period.
- ECOG performance score 0-3
- Life expectancy \> 12 weeks
- Laboratory parameters:
- Hematology
- Neutrophils \> 1,500/µl
- Platelets \> 100,000/µl
- Hemoglobin \>= 9 g/dl or 5.59 mmol/l Hemastasiology
- INR \<= 1.5 x ULN and aPTT \<= 1.5 x ULN within past 7 dClinical chemistry
- Creatinine clearance \> 30 ml/min, serum creatinine \< 2.5 x ULN
- Serum bilirubin \< 3.0 x ULN
- Alkaline phosphatase and transaminases \< 3.0 x ULN (in case of liver metastases \< 7 x ULN)
- Urinalysis:
- Patients with \< 2+ proteinuria on dipstick urinalysis.
- Patients with \>= 2+ proteinuria on dipstick urinalysis, who demonstrate \< 2.0 g of protein/24 h on 24-h urine collection
Exclusion
- Concomitant malignancies other than gastrointestinal cancers (Patients with curatively treated basal and squamous cell carcino¬ma of the skin and / or in-situ carci¬noma of the cervix are eli¬gible).
- Bacterial peritonitis as indicated by laboratory results (neutrophil count \> 250 / µl ascites) or clinical suspicion
- Hemorrhagic ascites (ascites hematocrit \> 2%)
- Transudative ascites (total protein in ascites \< 30 g/l)
- Parallel treatment with anti-tumor agents other than the study medication from inclusion into the study until safety follow-up. Chemotherapy may be continued if started before screening phase (- 4 weeks before inclusion). Parallel Treatment with Bevacizumab i.v. is not allowed.
- Therapy naïve patients
- Parallel treatment of ascites with measures other than para¬centesis, diuretics, and the study drugs from 4 weeks before inclusion into the study until safety follow-up.
- Patients with extensive metastases of the liver making up \> 70% of the total liver mass
- Child C cirrhosis of the liver
- Occlusion or thrombosis of the portal vein.
- Evidence of current and symptomatic central nervous system (CNS) metas¬ta¬ses or spinal cord compression.
- Clinically significant cardiovascular diseases, e.g., un¬con¬trolled hypertension, uncontrolled arrhythmia, hemoptoe, cardiovascular accident within the last 6 months before treatment start, unstable angina, congestive heart failure (CHF) NYHA grade III/IV, symptomatic coronary heart disease, peripheral arterial disease stage \>= II.
- History of fistula formation involving an internal organ (e.g. tracheo-oesophagal, bronchopleural, biliary, vagina and bladder)
- Major surgical procedure, open biopsy, or significant trau¬matic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
- Concomitant treatment with intravenous Bevacizumab for primary malignancy from inclusion into study until safety follow-up. Prior treatment with Bevacizumab for primary malignancy is not exclusionary.
- Serious non-healing wound, ulcer or bone fracture.
- Radiotherapy for purposes other than local control of symp¬toms.
- Evidence of bleeding diathesis or coagulopathy.
- Hematopoietic diseases.
- Known intra-abdominal inflammatory process or serious gastrointestinal ulceration.
- History of chronic intestinal diseases associated with severe diarrhea.
- Thrombo-embolic events or severe hemorrhage (\<= 6 months before treatment start).
- Known hypersensitivity to the test drug Bevacizumab
- Evidence of any other disease, metabolic dysfunction, physi¬cal examination finding, or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related compli¬cations.
- With the only exception of full dose (INR \> 1.5) oral coumarin-derived anticoagulants, the use of full dose anticoagulants is allowed as long as the INR or a PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for at least two weeks at the time of randomisation.
- Patients who participated within the last 30 days prior to enrolment in a clinical trial and received a non approved investigational drug (e.g. follow up within the trial is not exclusionary).
- Patients who have participated in this study before.
- Women, lactating, pregnant or of childbearing potential and fertile men not using a highly effective contraceptive method . \[Women of childbearing potential must have a negative pregnancy test (serum ß HCG) within 7 days before the first dose of study drug\].
- Patients who are committed to an institution by virtue of an order issued either by the judicial or the administra¬tive authorities (according to § 40 (1) 4 AMG).
- Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 (4) and § 41 (2) and (3) AMG).
- Patients with a history of a psychological illness or con¬di¬tion such as to interfere with the patient's ability to un¬der¬stand the requirements of the study.
- Patients who possibly are dependent on the sponsor or investigator.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01200121
Start Date
February 1 2010
End Date
December 1 2014
Last Update
April 13 2015
Active Locations (26)
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1
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie
Ludwigsburg, Baden-Wurttemberg, Germany, 71640
2
Onkologische Schwerpunktpraxis
Wendlingen, Baden-Wurttemberg, Germany, 73240
3
Klinikum Deggendorf, Medizinische Klinik II
Deggendorf, Bavaria, Germany, 94469
4
Ernst von Bergmann Klinikum, Zentrum für Hämatologie/Onkologie/Strahlenheilkunde
Potsdam, Brandenburg, Germany, 14467