Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites

Refractory Malignant Ascites Clinical Trial

Official title:

Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01852409
• Other study ID #: CGOG6001
• Status: Recruiting
• Phase: Phase 1
• First received: May 8, 2013
• Last updated: May 19, 2013
• Start date: May 2013
• Est. completion date: June 2015

Study information

• Verified date: May 2013
• Source: Peking University
• Contact: Lin Shen, M.D.
• Phone: 861088196561
• Email: lin100[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Refractory Malignant Ascites

Intervention

Drug:
• bevacizumab

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Maximum tolerated dose	during the treatment in the hosptital	1 week	Yes
Secondary	Objective response rate	ultrasound will be performed every week for efficacy evaluation	1 week	Yes
Secondary	time to treatment failure(TTF)	the follow-up visit of time to TTF will be performed every 4 weeks	1 month	No
Secondary	time to death(TTD)	TTD means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost	2 months	No