Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites

Peking University

Status and phase: Unknown; Phase 1

Conditions: Refractory Malignant Ascites

Treatments: Drug: bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01852409

CGOG6001

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent form;
2. 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;
3. failed to standard systemic therapy and / or no appropriate treatment for the treatment for malignant ascites
4. Age 18-70 years;
5. Performance Status- Eastern Cooperative Oncology Group (ECOG)≤2;
6. Life expectancy of at least 8 weeks;

Exclusion criteria

1. systematic anti-cancer therapy, including chemotherapy (intraperitoneal chemotherapy), radiation therapy, immunotherapy, biological or hormone therapy performed within 2 weeks;
2. tyrosine kinase inhibitors or monoclonal antibodies of anti-vascular endothelial growth factor (VEGF) performed within 4 weeks;
3. 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;
4. uncontrolled hypertension:systolic pressure ≥160 mmHg,or diastolic pressure≥100mmHg
5. Known history of severe heart disease,uncontrolled or symptomatic angina, congestive heart failure,clinically significant arrhythmias,myocardial infarction within six months;
6. active (severe or uncontrolled) bleeding (hemorrhage within 3 months> 30 ml), hemoptysis (fresh blood, 4 weeks> 5 ml), bloody ascites
7. thrombosis, tumor thrombus events (including arterial/venous thrombosis, tumor thrombosis, pulmonary embolism, transient ischemic attack)within 12 months;
8. Portal hypertensive disease or severe liver disease, including various types of cirrhosis, obstructive jaundice;
9. 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;
10. concurrent severe respiratory disease, or chronic therapy with oxygen or corticosteroids, such as chronic obstructive pulmonary disease, interstitial lung disease, etc.
11. Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2 or not recovered from surgery;
12. Symptomatic brain metastasis;
13. Uncontrolled systemic disease,such as infection,unstable diabetes mellitus,etc;
14. Active infection of HIV、HBV、HCV；
15. Major surgery within 4 weeks of start of study treatment, without complete recovery.
16. Pregnant or lactating women.Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception.
17. Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
18. Received any investigational drug treatment within 4 weeks of start of study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

bevacizumab

Experimental group

Description:

The study evaluate 4 dose level of bevacizumab:2.5mg /kg;5 mg /kg;7.5mg /kg; 1.25mg /kg;

Treatment:

Drug: bevacizumab