Status:
UNKNOWN
Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites
Lead Sponsor:
Peking University
Conditions:
Refractory Malignant Ascites
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
- Pregnant or lactating women.Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception.
- Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
- Received any investigational drug treatment within 4 weeks of start of study treatment.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01852409
Start Date
May 1 2013
End Date
June 1 2015
Last Update
May 21 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142