Clinical trial NCT02496286: Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
Official title: Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Malignant Ascites
Keywords: Necessary paracentesis for symptom control
Lead sponsor: Eastern Regional Medical Center
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of intraperitoneal administration of Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.

Detailed description: This protocol describes a pilot study to assess whether intraperitoneal Bevacizumab infusion is safe and improves the time to repeat paracentesis. In patients with non-draining malignant peritoneal effusion, published data suggests that the average time to repeat paracentesis in malignant ascites is 10-13 Days. The investigators' treatment will be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days.

Eligibility criteria: Inclusion Criteria:

* Patients will be included in the case of:

  * Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
  * Participants must be 18 years of age or older
  * Have ascites of malignant disease
  * Have symptoms related to ascites
  * Ascites Index above 0.05 (AI ˃ 0.05)
  * Be an English speaking patient or have an interpreter available
  * Be able to understand and comply with all study requirements and the implications of off-label use of intraperitoneal Bevacizumab
  * Have had at least two paracentesis within the last 4 weeks

Exclusion Criteria:

* Patients will be excluded in the case of:

  * Ascites due to non-malignant cause
  * Concurrent treatment with systemic chemotherapy that has a realistic chance of controlling the ascites
  * Concurrent treatment with intraperitoneal Bevacizumab
  * life expectancy of less than 2 weeks
  * A history of bowel perforation or fistula
  * Symptoms or signs suggestive of bacterial peritonitis
  * Child's C cirrhosis
  * Uncontrolled hypertension
  * Surgery within 28 days of catheter treatment
  * Evidence of coagulopathy
  * Symptoms suggestive of bowel obstruction
  * Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
  * Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
  * Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
  * Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation)
  * Patients with pre-existing 3 + or greater urine dipstick reading proteinuria

Primary outcomes:
measure: Radiographic Improvement
timeFrame: 14 days (+/-4 days)
measure: Volume Output
timeFrame: 14 days (+/-4 days)
Secondary outcomes:
measure: Adverse Events
timeFrame: 14 days (+/-4 days)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
Study officials:
References: