Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites
1 other identifier
interventional
18
1 country
2
Brief Summary
Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab for the palliation of malignant ascites might be a novel choice for refractory malignant ascites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2013
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 21, 2013
May 1, 2013
2.1 years
May 8, 2013
May 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
adverse events
participants will be followed for the duration of hospital stay, an expected average of 1 week
during the treatment in the hospital,an expected average of 1 week
Maximum tolerated dose
during the treatment in the hosptital
1 week
Secondary Outcomes (3)
Objective response rate
1 week
time to treatment failure(TTF)
1 month
time to death(TTD)
2 months
Study Arms (1)
bevacizumab
EXPERIMENTALThe study evaluate 4 dose level of bevacizumab:2.5mg /kg;5 mg /kg;7.5mg /kg; 1.25mg /kg;
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent form;
- Histologically or cytologically confirmed non-squamous cell carcinoma，including colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, bile duct cancer, ovarian cancer, peritoneal primary tumor;Ascites were diagnosed by ultrasound or CT and confirmed malignant ascites by cytology;
- failed to standard systemic therapy and / or no appropriate treatment for the treatment for malignant ascites
- Age 18-70 years;
- Performance Status- Eastern Cooperative Oncology Group (ECOG)≤2;
- Life expectancy of at least 8 weeks;
You may not qualify if:
- systematic anti-cancer therapy, including chemotherapy (intraperitoneal chemotherapy), radiation therapy, immunotherapy, biological or hormone therapy performed within 2 weeks;
- tyrosine kinase inhibitors or monoclonal antibodies of anti-vascular endothelial growth factor (VEGF) performed within 4 weeks;
- Laboratory tests:Absolute neutrophil count\<1.0x109/L,Platelet count\<75x 109/L,Hemoglobin\<8g/dl,PT-INR≥1.5 times upper limit of normal (ULN);Bilirubin≥2 x ULN,AST and ALT≥2.5 times ULN(no liver metastasis),≥5 times ULN(with liver metastasis)Creatinine≥1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula,\<40 mL/min;
- uncontrolled hypertension:systolic pressure ≥160 mmHg,or diastolic pressure≥100mmHg
- Known history of severe heart disease,uncontrolled or symptomatic angina, congestive heart failure,clinically significant arrhythmias,myocardial infarction within six months;
- active (severe or uncontrolled) bleeding (hemorrhage within 3 months\> 30 ml), hemoptysis (fresh blood, 4 weeks\> 5 ml), bloody ascites
- thrombosis, tumor thrombus events (including arterial/venous thrombosis, tumor thrombosis, pulmonary embolism, transient ischemic attack)within 12 months;
- Portal hypertensive disease or severe liver disease, including various types of cirrhosis, obstructive jaundice;
- concurrent gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases according to investigators' determination that may cause gastrointestinal bleeding or perforation;
- concurrent severe respiratory disease, or chronic therapy with oxygen or corticosteroids, such as chronic obstructive pulmonary disease, interstitial lung disease, etc.
- Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2 or not recovered from surgery;
- Symptomatic brain metastasis;
- Uncontrolled systemic disease,such as infection,unstable diabetes mellitus,etc;
- Active infection of HIV、HBV、HCV；
- Major surgery within 4 weeks of start of study treatment, without complete recovery.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Related Publications (1)
Kou F, Gong J, Li Y, Li J, Zhang X, Li J, Shen L. Phase I study of intraperitoneal bevacizumab for treating refractory malignant ascites. J Int Med Res. 2021 Feb;49(2):300060520986664. doi: 10.1177/0300060520986664.
PMID: 33616416DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of GI oncology
Study Record Dates
First Submitted
May 8, 2013
First Posted
May 13, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 21, 2013
Record last verified: 2013-05